Careers at ViaCyte

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical-stage development. The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

The incumbent will perform a broad range of tasks in the cGMP manufacture of cells and combination cell therapy/device products for use in clinical and developmental studies. This position includes hands-on participation, including materials logistics, assisting in manufacturing operations, and may include non-routine development activities. This is a full-time position.
1. Assist in manufacturing operations to produce GMP grade PEC-01 and Combination Product to meet corporate goals.
2. Assist in ensuring that there are sufficient materials available for all production runs or campaigns, including media, small molecules, and growth factors.
3. Provide hands-on support for scale-up and development activities as needed based on a demand plan.
4. Understand and review applicable GMP documentation, including batch records, SOP’s, deviations, change requests, CAPA’s, IOQ’s, technical reports, and other documents.
5. Maintain current training status for all applicable activities.
6. Assist in maintaining GMP areas in a constant state of inspection readiness related to equipment and area preventive maintenance, calibration, and certification.
7. Throughout the course of all job activities, maintain accurate records and documentation required to support regulatory submissions, and comply with regulatory requirements.

Experience

1. Experience culturing human embryonic stem cells is preferred.
2. Current knowledge and understanding of GMP principles and requirements as applied to the biotechnology manufacturing industry is preferred.
3. Ability to effectively coordinate department activities with different functional groups within the manufacturing and operations departments.
4. The ability to perform some weekend work is required.             5. Must be skilled in Microsoft Office, including Word, Excel, and PowerPoint.
6. Good verbal and written communication skills are preferred. Must be able to write and speak effectively across multiple departments/disciplines.
Education & Work Experience

Requirements

1. A college degree in a biological or engineering science is preferred.
2. A minimum of 1 year of experience in cell culture-based manufacturing or development operations is preferred.
An equivalent combination of education and experience with cell culture manufacturing processes sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-5 and your full name. Send to hr@viacyte.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.
ViaCyte’s goal is to increase the representation of women, people of color, veterans, and individuals with disabilities. Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations and cover all human resource actions, including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical-stage development. The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

Incumbent will organize, supervise and perform a broad range of tasks in the cGMP manufacture of cells and combination cell therapy/device products for use in clinical and developmental studies. This position includes hands-on participation including materials logistics, manufacturing operations, and non-routine development activities. This is a full-time position.

Position Requirements

1. Experience culturing human embryonic stem cells is preferred.
2. Current knowledge and understanding of GMP principles and requirements as applied to the biotechnology manufacturing industry is preferred.
3. Ability to effectively coordinate department activities with different functional groups within the manufacturing and operations departments.
4. The ability to perform some weekend work is required.
5. Must be skilled in Microsoft Office, including Word, Excel, and PowerPoint.
6. Good verbal and written communication skills are preferred. Must be able to write and speak effectively across multiple departments/disciplines.

Position Responsibilities

Organize material logistics and manufacturing operations to produce GMP grade product to meet corporate goals.
Assure sufficient materials are available for all production runs or campaigns including media, small molecules, and growth factors.
Support material release testing as needed.
Provide hands on support for scale up/out and development activities as needed based on a demand plan.
Generate and review applicable GMP documentation including batch records, SOP’s, deviations, change requests, CAPA’s, IOQ’s, technical reports, and other documents.
Maintain current training status for all applicable activities.
Maintain GMP area in a constant state of inspection readiness related to equipment and area preventive
maintenance, calibration, and certification.
Throughout the course of all job activities, maintain accurate records and documentation required to support regulatory submissions and comply with regulatory requirements.

Education

A college degree in a biological or engineering science is required.
Minimum of 10 years of experience in cell culture-based manufacturing or development operations is preferred.
An equivalent combination of education and experience with cell culture manufacturing processes sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-26 and your full name. Send to hr@viacyte.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.
ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities.
Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical-stage development. The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

As a member of the Engineering team, the engineer shall support product development, process development, and manufacturing activities. The employee shall utilize R&D methods and engineering techniques to design and develop new devices and combination products, develop processes, generate test systems, and improve manufacturing procedures. Engineer shall also support the development of new surgical procedures, write and execute engineering protocols, and document reports, and all elements necessary to launch products through design control.

Requirements

1. Product Development: Conceive, design, develop, test, and refine cost-effective device or combination product prototypes to enable in vitro and in vivo testing. This includes supporting the development of new surgical procedures. Conduct studies to demonstrate the feasibility of a product concept. Define product requirements and specifications. Develop processes necessary to fabricate devices or combination products. Develop and implement test methods for assessing the quality of in-process and finished products. Develop, execute, and analyze design verification and validation studies, culminating in a design history file.
2. Project Management / Leadership: Lead projects of small to moderate scope as a project manager. May coordinate activities of other junior personnel. Work with other Engineering and cross-functional employees to achieve company and department milestones on time and on budget. Maintain flexibility in a highly dynamic, cross-functional environment working with highly dedicated cross-functional colleagues in a culture focused on continuous improvement.
3. Manufacturing Support: Identify and implement improvements to manufacturing processes and process flow. Develop fixturing or other tools necessary for efficient manufacturing operations. Conduct equipment preventative maintenance or qualification studies as necessary. Conduct preclinical build operations as necessary. Initiate and define process validation activities.
4. Quality Support: Write, amend, and review SOP’s, batch records, raw material specifications, drawings, and other documentation as required to support product manufacturing and quality control testing. Identify and drive resolution of non-conforming material (NCMRs) or corrective actions (CAPAs).
5. Clinical Support: Attend clinical procedures, document findings, synthesize, and drive advancements in clinical procedures necessary to achieve safety and efficacy targets.
6. Engineering / Scientific Acumen: Generate and present scientific data, including scientific papers and research reports. Work cross-functionally with scientists to generate preclinical study concepts, and work collaboratively to conduct study and report out results.

Experience

1. Strong verbal and written communication skills are required. Must be able to summarize and communicate technical concepts effectively.
2. Must be skilled in identifying complex scientific problems and experimental hurdles, and in solving those problems.
3. Class II or III medical device or combination product experience required.
4. Must be proficient in performing independent research under minimal supervision and within short timelines.
5. Experience with statistics, experimental design, and data analysis fundamentals
6. Must have experience with FDA Quality Systems Regulations, Design Controls, and ISO 13485-related documentation preparation.
7. Experience with cell culture, tissue culture, and cell handling strongly preferred.
8. Strong theoretical knowledge of materials and mechanics preferred.
9. Experience operating in clean rooms, aseptic handling practices preferred.
10. Advanced experience using CAD, SolidWorks preferred.

Education

B.S., M.S., or Ph.D. in chemical, mechanical, biomedical engineering, or related field is required. Minimum of five years of work experience in medical device development.
An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-12 and your full name. Send to hr@viacyte.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.
ViaCyte’s goal is to increase representation of women, people of color, veterans, and individuals with disabilities. Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

As a member of the Engineering team, the engineer shall support product development, process development, and manufacturing activities.  The employee shall utilize R&D methods and engineering techniques to design and develop new devices and combination products, develop processes, generate test systems, and improve manufacturing procedures.  Engineer shall also write and execute engineering protocols, and document reports and all elements necessary to launch products through design control.  This engineer shall be a thought-leader and subject matter expert in the organization, as evidenced by design concepts brought to fruition, novel processes, and/or patents, papers, or presentations.

Essential Duties & Responsibilities

1. Product Development: Lead, conceive, design, develop, test, and refine cost-effective device or combination product prototypes to enable in vitro and in vivo Conduct studies to demonstrate the feasibility of a product concept. Demonstrates deep insight regarding design intent and uses insight to drive product requirements and specifications.  Develop processes necessary to fabricate devices or combination products.  Develop and implement test methods for assessing the quality of in-process and finished products. Develop, execute, and analyze design verification and validation studies, culminating in a design history file.
2. Technical Leadership: Lead research and development projects of strategic scope as a key technical contributor. Recognized as an SME within ViaCyte on two or more substantive technical topics.  May coordinate activities of other personnel.  Work with other Engineering and cross-functional employees to achieve company and department milestones on time and on budget.  Maintain flexibility in a highly dynamic, cross-functional environment working with highly dedicated cross-functional colleagues in a culture focused on continuous improvement.
3. Manufacturing Support: Identify and implement improvements to manufacturing processes and process flow. Develop fixturing or other tools necessary for efficient manufacturing operations.  Conduct equipment preventative maintenance or qualification studies as necessary.  Conduct preclinical build operations as necessary.  Initiate, define, and execute process validation activities.
4. Quality Support: Write, amend, and review SOP’s, batch records, raw material specifications, drawings, and other documentation as required to support product manufacturing and quality control testing. Identify and drive resolution of non-conforming material (NCMRs) or corrective actions (CAPAs).
5. Clinical Support: Attend clinical procedures, document findings, synthesize, and drive advancements in clinical procedures necessary to achieve safety and efficacy targets.
6. Engineering / Scientific Acumen: Generate and present scientific data, including scientific papers and research reports. Work cross-functionally with scientists to generate preclinical study concepts, and work collaboratively to conduct study and report out results.

Required Experience

• Strong verbal and written communication skills are required. Must be able to summarize and communicate technical concepts effectively.
• Development experience of Class II or III implantable medical devices required. Familiarity with laparoscopic surgery is strongly preferred.
• Must possess fundamental and applied knowledge related to engineering principles and material science
• Must possess fundamental understanding and application of statistical methods, experimental design, and advanced data analysis.
• Must work efficiently both independently and within a team, mentoring junior engineers as needed.
• Experience with project management concepts and fundamentals
• Must have experience with FDA Quality Systems Regulations, Design Controls, and ISO 13485-related documentation preparation.
• Experience with cell culture, tissue culture, and cell handling strongly preferred.
• Experience operating in clean rooms, aseptic handling practices preferred.
• Advanced experience using CAD, SolidWorks preferred.

Education & Work Experience

B.S., M.S., or PhD, mechanical, chemical or biomedical engineering or related field is required. Graduate degree strongly preferred.  Minimum of ten years of work experience in medical device development.

An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-24-1,2 and your full name.  Send to hr@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans, and individuals with disabilities. Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations, and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.

Company Overview

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

The HR Benefits Specialist role is to provide comprehensive Human Resources (HR) support for the administration, communication and compliance for employee benefit programs, including but not limited to health and ancillary coverage, 401(k), worker’s compensation, leaves of absence coordination and management and health and wellness programs. Additionally, this role will closely manage the COVID-19 day-to-day responsibilities.

Essential Duties and Responsibilities

1. Serve as first line of contact to employees and managers on questions relating to employee benefits, health and wellness, COVID-19, leaves of absences, safety and/or worker’s compensation policies and procedures.
2. Provide employee training for workplace social distancing and sanitation protocols.
3. Maintain appropriate contact with employees and coordinate all aspects of return to work (i.e. illness, travel, injury, leaves, etc.), ensuring COVID-19 policies and procedures are followed.
4. Coordinate, track and manage employee COVID-19 testing, as appropriate.
5. Follow the latest local, state and public health guidance for COVID-19 and make recommendations as needed.
6. Build and organize onboarding activities for all company employee benefit programs.
7. Responsible for day-to-day benefits support activities, including, but not limited to: assisting employees with questions and resolution of benefits matters, processing participant enrollments, changes, and terminations, verifying and approving invoices for payment and completing periodic compliance reports.
8. Lead annual evaluation of benefit plan design and pricing, including arranging renewal meetings, preparing cost and coverage analyses, providing recommendations and facilitating final plan selections.
9. Organize open enrollment activities for benefits programs, such as preparing census data, scheduling meetings, compiling benefit materials, communicating logistics and deadlines to employees, and educating employees on plan designs and selections.
10. Coordinate administration of 401(k) plan, including but not limited to: processing enrollments, changes, terminations, and 401(k) loans, arranging financial education seminars, coordinating investment committee meetings, complying with periodic disclosure requirements and assisting with other compliance tasks.
11. Administer and oversee disability/workers compensation claims and leave of absence programs, including but not limited to: processing forms, verifying and coordinating appropriate salary adjustments with payroll, and working with case managers and employee claimants to ensure proper compliance and accurate compensation.
12. Certify and track leaves of absence according to applicable law and company policies, ensuring appropriate designation of leave(s).
13. Maintain effective system of communication/notification, and work jointly with payroll to ensure any changes affecting employees (calculation of pay adjustments, benefit enrollments, leaves of absence, etc.) are processed timely and accurately.
14. Conducts or assists with record audits, mandatory reporting, and/or various HR surveys which may include I-9 audits, EEO-1 filings, ACA reporting, compensation and/or benefit surveys, workers compensation and payroll audits, and other compliance reviews.
15. Assist with updating any HR policies, procedures and processes that support business needs and objectives.  Identifies opportunities to clarify existing policies and improve any existing procedures and/or systems in line with company needs.
16. Participate and/or assist with events and activities to enhance employee relations.
17. Perform other related duties as required and assigned.

Educational Background:

Bachelor’s degree in Human Resources, Business Administration, or related field and a minimum of 5 years of experience in human resources/benefits related support and administration.  An equivalent combination of education, training and direct experience sufficient to successfully perform the job duties as listed above is acceptable.

HR certification and active affiliation with appropriate Human Resources networks and organizations is a plus.

Experience/Knowledge/Abilities:

• Thorough working knowledge of applicable employment related and leave laws and regulations for state, federal and/or local jurisdictions, including but not limited to: ADA, FMLA, CFRA, CA PDL and PFL.
• Familiar with HIPAA regulations.
• Ability to work independently and proactively, with minimal instruction and supervision, while working in a fast-paced environment with multiple deadlines and frequently changing priorities.
• Superior oral, written, and interpersonal skills including ability to communicate effectively with people individually and in large groups.
• Independent thinker with excellent organizational skills, with solid follow-up and follow-through and strong attention to detail.
• Excellent time management skills with a proven ability to consistently deliver quality work and meet deadlines.
• Ability to perform duties with integrity, professionalism, and strict confidentiality.
• Ability to maintain and build strong work relationships and actively seek opportunities to influence, build trust and gain alignment with peers, functional leaders and/or external partners to accomplish tasks and business objectives.
• Strong analytical, critical thinking, mathematical, planning and problem-solving skills.
• Proficient with Microsoft Office Suite and proficiency with and/or the ability to quickly learn the organization’s HRIS and/or other HR related software and systems.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-28 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

This scientist will be expected to work in a highly collaborative team environment, leading some projects independently and others with some supervision of a senior scientist. This is a full-time position.

• Gene editing using CRISPR/Cas9 in human pluripotent stem cells (PSCs, including ESCs and iPSCs) and generate seedbanks from selected clones using aseptic techniques.
• Collaborate with other team members in large-scale growth, passage, and differentiation of gene edited human pluripotent stem cells using aseptic technique to manufacture cellular product.
• Analyze the progression of cell differentiation in vitro using real time gene expression using Nanostring platform. Analyze assay results utilizing statistical analysis tools.
• Understand applicable documentation, including batch records, SOP’s, deviations, change requests, IOQ’s, and other documents. Generate batch records, SOP’s, change requests, study protocols, study reports and other documents as needed throughout the course of all job activities, maintain accurate records and documentation.
• Ability to effectively coordinate department activities with different functional groups within the company and with external collaborators.
• Present data and findings to peers and managers.
• Prioritize work across multiple projects.
• Highly self-motivated and flexibility in working schedule to accommodate weekend work when necessary.
• Flexibility to handle rapidly changing objectives and timelines is essential.

Requirements

• Ph.D. in a biological science discipline with 3+ years of relevant gene editing experience.
• Extensive knowledge and experience with CRISPR/Cas9 gene editing.
• Extensive Pluripotent stem cell culture experience is required.
• Knowledge of stem cell biology and/or developmental biology is required.
• Knowledge of clean room procedures and experience working in a clean room is highly desirable.
• Experience with molecular biology techniques especially RNA extraction, Nanostring, viability, cell death assays and ELISA is required.
• Must be skilled in the Windows operating system and Microsoft Office, primarily Word, Excel and PowerPoint.
• Detail-orientated, organized, strong time management skills with the capacity to meet deadlines and prioritize work from multiple projects.
• Excellent oral and written technical communication skills.
• Strong sense of responsibility, accountability, and integrity.

An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-29 and your full name.  Send to hr@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

Key Responsibilities

• Provide regulatory support (defined in Section III.2.c) to product development objectives through organized and timely regulatory submissions.
• Ensure that the timing and content of regulatory submissions meet regulatory agency expectations and achieve regulatory clearance without delaying manufacturing timelines, clinical trial timelines and other development activities.
• By organizing effective document review processes ensure completeness, accuracy and appropriate messaging of regulatory submissions.
• Proactively assist development teams and management in awareness and understanding of new and evolving regulatory requirements and their impacts.
• Contribute to continuous improvement through the QMS.
• Ability to project a positive constructive attitude in communications to inspire cooperation and teamwork among peers and management members.

Qualifications

Education & Work Experience Requirements

• Minimum of a bachelor’s degree in biological sciences or related field is required.
• Regional scope: 5 years’ experience in providing regulatory support to sponsors (manufacturers, specification developers and/or dossier applicants) in U.S.; experience with Canada, UK, or EMA or EU member states is a plus.
• Product life-cycle scope: Experience with investigational medical products development; experience with commercial stage medical products is desired.
• Regulatory support scope: Experience providing such work products as: clinical trial applications (INDs), amendments and associated meeting packages and written communications for biological drug products; medical device pre-market clearance applications (510(k)s, PMAs) in combination with parenteral biologic or drug products, and associated pre-submission packages; or biologic or drug product market authorization applications (NDA’s, BLA’s, MAA’s or PMA’s); maintaining logs and archives of searchable and retrievable regulatory agency written and verbal communications.

Experience/Knowledge/Abilities

• Knowledge of regulatory requirements for cellular therapies.
• Experience with sterile products or parenteral products requiring aseptic processing.
• Computer skills and written communication skills in order to complete the reports and paperwork required by regulatory bodies.
• Expert level familiarity with applicable biological drug and medical device regulations and guidelines issued by standards agencies (e.g., ICH, ISO, PDA) and regulatory agencies.
• Effective communication skills to keep other managers and department heads informed of regulations and policies with which they must comply.
• Must be highly organized and possess meticulous attention to detail.
• Strong communication skills, both written and verbal, are required.
• Must be skilled in Microsoft Office, including Word and Excel.
• Ability to project a positive constructive attitude in communications to inspire cooperation and teamwork among peers and management members.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-33 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

The Clinical Trial Assistant will assist and work in collaboration with a Sr. Clinical Trial Manager (or another member of the departmental leadership team), to ensure timely completion of program activities.  The essential duties and responsibilities will include, but are not limited to:

• Manage various aspects of day-to-day operations of clinical trials as assigned.
• Provide general support to the Sr. Clinical Trial Manager (CTM) or CTM and field Clinical Research Associates (CRAs) to manage the investigator sites and ensure compliance.
• Manage the collection, review and tracking of essential regulatory documents in support of new clinical study site activation.
• Manage and serve as a point of contact for contract research organization (CRO) and third-party vendors; identifying potential risks and proactively resolving issues that arise.
• Ensure all clinical sites are provisioned with appropriate ancillary supplies, investigational product, and associated documentation by establishing purchase orders, processing orders, and arranging for delivery by vendors and/or internal departments as necessary.
• Collect and process clinical site surgical notification forms; add surgical procedures to calendar from study-specific distribution list.
• Manage all investigational product (IP) requests, including, but not limited to: IP manufacturing requests, tracking of all IP shipping and delivery, IP accountability logs, and inventory reports.
• Create explant plans for review by CTM; send plan to clinical site and update internal calendar as needed.
• Upload study procedure surgical photos and videos to local drives.
• Establish templates within electronic Trial Master File (eTMF) system.
• Collect and process electronic case report form (eCRF) access requests from clinical sites and internal team members.
• Assist in the development of reports for communicating study progress and key metrics to the management team.
• As needed, travel to investigator sites to assist with site monitoring, reviewing source documents, CRF entries, regulatory files, IP accountability records, and all other relevant study documents to ensure site compliance and data validity.
• Schedule & set up necessary tele- or videoconferencing meeting requirements for Clinical Development team as needed.
• Capture and file minutes for in-house meetings and conference calls with CROs, vendors, and cross-functional teams.
• Review and update Standard Operating Procedures (SOPs).
• Maintain effective communication with study teams throughout study cycle.
• Complete other study-related tasks as required by Clinical Development Team members.

Our dynamic workplace is attractive to those who are self-motivated and resourceful.  You will be expected to set priorities within your job scope and to meet critical deadlines.  Flexibility to handle rapidly changing objectives and timelines is essential.

Requirements

• This position requires a bachelor’s degree, life sciences preferred, and a minimum of 3 years of biotechnology or industry related project management experience are required.
• An equivalent combination of education and experience is sufficient to successfully perform the job duties is acceptable.
• Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements is necessary.
• Familiarity with diabetes, metabolic disease, cell therapy, and/or cutting edge translational medicine is strongly desired.
• Strong verbal and written communication skills are required including ability to organize and present concepts with written, oral, and technical media / approaches.
• Candidates must be skilled in Windows, Microsoft Project, and Microsoft Office.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-32 and your full name.  Send to hr@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

The Senior Clinical Trial Manager will assist and work in collaboration with the Director, Clinical Development (or another member of the departmental leadership team), to ensure timely completion of program activities.  The essential duties and responsibilities will include, but are not limited to:

• Effective management of day-to-day operations of multiple clinical trials.
• Lead, organize, assign, and track tasks assigned to clinical team members (e.g., consultants or in-house team) on assigned studies.
• Lead individual clinical trial team meetings for assigned studies
• Establish and maintain assigned trial timelines to ensure alignment with the Clinical Development Plan
• Drive timely enrollment of trial participants for assigned studies
• Assist with development and implementation of internal procedures to support ICH and GCP adherence during clinical trials
• Create and track assigned study budget(s) to ensure spend remains within target.
• Ensure costs for assigned trials are captured in purchase orders and review of trial-specific vendor invoices
• Ability to directly conduct the identification, RFP and selection process for key trial vendors
• Manage and oversee the performance of vendors (including CROs) for assigned clinical trials by acting as the primary interface.
• Participate in meetings and conference calls with CROs, vendors, and cross-functional teams as required.
• Ability to independently negotiate and contract vendor work orders for assigned clinical trials. May assist efforts to establish service agreements with new vendors
• Ability to directly conduct site budget negotiations and contracting
• Provide program director with trial status updates and reports on assigned trial activities.
• Coordinate efforts by assigned clinical team member(s) to provision sites with investigational product, ancillary supplies, and associated documentation.
• Author draft(s) of clinical trial protocols and amendments for assigned studies. Coordinate cross-functional review as required.
• Provide content as requested for regulatory submissions related to assigned trials. May be required to author clinical sections of submissions
• Ensure potential subject safety issues are communicated to appropriate parties as identified.
• Contribute information from assigned trials for inclusion in DSMB and CAB meeting materials.
• Ensure creation of key study documents (e.g. informed consent document, case report forms, monitoring plan, and clinical study reports) via oversight of assigned team members and thru directly authoring as needed.
• Ability to coordinate creation of and directly review data listings (with assigned team members) for preparation of interim/final clinical study reports, DSURs, DSMBs, or as needed.
• Mentoring of junior department members required. Line management responsibilities likely required.
• Oversight of consultant work assignments for all assigned trials; may be required to establish consultant agreements
• Assist with additional tasks as assigned by departmental senior leaders Overnight travel required as much as 10%

Our dynamic workplace is attractive to those who are self-motivated and resourceful.  You will be expected to set priorities within your job scope and to meet critical deadlines.  Flexibility to handle rapidly changing objectives and timelines is essential.

Requirements

This position requires a bachelor’s degree, life sciences preferred, and a minimum of 3 years of biotechnology or industry related project management experience are required. An equivalent combination of education and experience is sufficient to successfully perform the job duties is acceptable.  Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements is necessary.  Familiarity with diabetes, metabolic disease, cell therapy, and/or cutting edge translational medicine is strongly desired.  Strong verbal and written communication skills are required including ability to organize and present concepts with written, oral, and technical media / approaches.  Candidates must be skilled in Windows, Microsoft Project, and Microsoft Office.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-31 and your full name.  Send to hr@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.

Company Overview

ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

Position Description

The Senior Data Manager will assist and work in collaboration with the Clinical Development Team, to ensure timely completion of program activities. This is a full-time position.

• Lead experience managing at least 3 studies simultaneously
• Will be primary point of contact to the wider clinical trial team for clinical trial data related matters
• Responsible for coordination of clinical data acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting
• Will participate in development of budget and timelines for client projects
• Responsible for CRF development based on protocol review
• Creation and/or review of data management plans, database specifications, edit check specifications and data entry guidelines
• Responsible to work directly with EDC developers in the development of quality and timely Electronic Case Report Forms (eCRFs); Centralized system and EDC system setup including UAT
• Responsible for ongoing data review and query management
• Receipt and archive of clinical trial data and/or data management documentation
• Responsible to coordinate coding for adverse events and concomitant medications
• Perform all DM responsibilities in accordance with company guidelines and Standard Operations Procedures and appropriate industry and regulatory standards and Good Clinical Practices.
• Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing data management services on behalf of Viacyte

Requirements:

• BA or BS in a life science, computer science, or related fields
• Minimum 7 years of experience in Data Management within the pharmaceutical/biotech industry
• Minimum 3 years in a Lead Data Manager role
• Ability to prepare complex data models unassisted and understand and model complex knowledge-intensive processes.
• Understanding of current industry standard best data management practices
• Familiar with the most common standard coding dictionaries and processes
• Strong initiative, excellent interpersonal and communication skills

Experience/Knowledge/Abilities:

• Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements is required.
• Familiarity with diabetes, metabolic disease, cell therapy, and/or cutting edge translational medicine is strongly desired.
• Must possess several competencies, including diligence, self-initiative, an ability to effectively convey information, and a predisposition for being highly organized.
• Must have strong interpersonal skills including the ability to work with different personalities and styles, moderate and mediate, build and maintain consensus, and turn work assignments into value-added actions.
• Strong verbal and written communication skills are required including ability to organize and present concepts with written, oral, and technical media / approaches.
• Ability to work in a fast-paced environment on complex projects is critical, including strong skill sets in organizing workload, time management, identifying and implementing strategies for improving efficiency, and effective timely execution and completion of parallel tasks.
• Must be skilled in the Windows operating system, Microsoft Project, and Microsoft Office, including Word, Excel, and Power Point.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-30 and your full name.  Send to hr@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.

Policy

It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.

ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.