Careers at ViaCyte

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

As a member of the team, incumbent will conduct animal studies evaluating safety, efficacy, and pharmacokinetics of human ES cell-derived diabetes therapies.  This is a full time position.

• Perform in vivo experiments, including implant surgeries on rodents, and other routine procedures, such as health monitoring, blood collection, drug administration, and necropsy.
• Assist with operational management of the vivarium, including interfacing with vivarium management and facilitating efficient resolutions to logistical and environmental problems.
• Assist in collecting and organizing study documentation from multiple researchers, such as notes, observations, and data, and enter into a central database.
• Assist in updating standard operating procedures and protocols for Institutional Animal Care and Use Committee (IACUC).
• Record and maintain accurate research documentation and perform analyses to identify non-conforming data points. Prepare written summaries of data for peer review.
• Contribute to the development of novel assays and adaptation of existing assays to comply with standards required of preclinical in vivo studies.
• Prepare, process, and retain documentation required to maintain DEA controlled substances license.
• Train staff of contract research organizations and collaborators in the execution of critical procedures.

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

BS degree in biology or related field is required.  Minimum 4 years industry experience is required.  Hands-on experience performing surgeries, dosing, and blood collection procedures on immunocompromised rodents is required.

• Experience with diabetes models in rodents is helpful.
• Knowledge of document control methods required in a preclinical environment is desirable, including ability to independently draft standard operating procedures.
• Knowledge of IACUC policies, and ability to draft study protocols and to complete applications, are required.
• Must be able to navigate multiple software environments, including Microsoft Office (Word, Excel, PowerPoint), documentation management software (QCBD, Signals), bioluminescence acquisition and image analysis software (Living Image), and statistical analysis software (jmp or minitab).
• Strong verbal and written communication skills are required. Must be able to draft technical reports and present data clearly and concisely.

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 2020-25 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.

Position Description

We seek to fill a full-time position within our Clinical Development team.  The Clinical Document Specialist will be responsible for all Clinical Development document management related to Electronic Trial Master File (eTMF) and other study-required files throughout all cycles of clinical trials.  Our work environment is well suited for an individual who will actively collaborate with team members to set priorities within the job scope and organize his or her own workload to meet expected requests and timelines.

• Manage various aspects of day-to-day operations of clinical document management using SimpleTrials Clinical Data Management System (SimpleTrials), Sharepoint and/or local network.
• Transition eTMF files currently housed in Sharepoint and/or local network to SimpleTrials.
• Assist in developing trackers for all required study-related documents and enrollment metrics.
• Track and file final versions of study documents in eTMF. Collect missing study documents as identified and file in appropriate eTMF location.
• Perform routine eTMF quality checks throughout the life cycle of a clinical study, ensuring that the essential documents are obtained, accurate, current, complete, and filed from study start-up through close-out activities. Verify that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, International Conference on Harmonization / Good Clinical Practice (ICH/GCP) guidelines and standard operating procedures (SOPs).
• Generate eTMF reports and resolve all discrepancies and issues identified in collaboration with study team.
• Enter and maintain all initial site and vendor contact information within SimpleTrials.
• Print, assemble and send Investigator Site File (ISF) binders to clinical sites.
• Request Non-Disclosure Agreements (NDAs) from in-house legal for new clinical sites and vendors.
• Submit 1572 and Clinical Trial Site Information (CTSI) forms and Principal Investigator Curriculum Vitae (CV) to in-house Regulatory Department.
• Establish and maintain study-specific email distribution lists, providing updates to list recipients as requested by Clinical Development team members.
• Participate in inspection-readiness activities, as needed.
• Schedule & set up necessary tele- or videoconferencing meeting requirements (i.e., GoToMeeting, Webex, etc.) for Clinical Development team as needed.
• Review and update SOPs in ViaCyte Quality Management System.
• Complete Clinical Development expense reports.
• Maintain effective communication with study teams throughout study cycle.
• Complete other study-related tasks as required by the Clinical Development team.

Requirements

A Bachelor’s degree or equivalent combination of education and experience, preferably in clinical research field.

• Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH) Guidelines, and other regulatory requirements is preferred.
• Must be able to prioritize multiple tasks.
• Must be skilled in Microsoft Office, including Word, Excel, and PowerPoint.
• Proficiency with SimpleTrials Clinical Data Management System is highly desired.
• Strong verbal and written communication skills are required. Must be able to draft technical documents and present data clearly and concisely.
• Organize own work based on established priorities.
• Flexibility to effectively handle rapidly changing objectives and timelines.
• Must possess mobility to work in office settings and to use equipment commonly found in these environments.
• Strength to lift and carry equipment and supplies weighing up to 50 pounds.
• Vision to read printed materials and on a computer screen; and hearing and speech to communicate in person and over the telephone.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, type Job Code #2020-02 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.

Position Description

The Clinical Trial Manager will assist and work in collaboration with the Director, Clinical Development, 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.
• Establish and maintain Clinical Development Plan timelines for ViaCyte clinical studies.
• Assist with the projection, tracking, management and analysis of study budgets by establishing purchase orders, maintaining study accounting spreadsheets, and reviewing, approving, and filing invoices for service and supply vendors.
• Select, manage, and oversee the performance of clinical trial vendors by acting as the primary interface with vendors, driving performance as per the scope of work, negotiating and updating agreements/change orders, and ensuring pertinent documentation is obtained and filed.
• Providing internal stakeholders with relevant status updates and information on trial activities to streamline company efforts.
• Lead, organize, assign, and track tasks assigned to clinical team members (e.g., consultants or in-house team) on studies managed internally.
• Ensure clinical sites are provisioned with appropriate supplies, investigational product, and associated documentation via coordination and scheduling of requests with internal resources.
• Facilitate efforts to identify potential subject safety issues by obtaining relevant data and distributing and/or reviewing reports.
• Assist with establishing and updating internal procedures to maintain adherence to clinical trial operations.
• Participate in meetings and conference calls with CROs, vendors, and cross-functional teams.
• Assist the CMO/Director/Sr. Director with additional tasks as assigned.

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 2020-03 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.

Position Description

As a member of the Combination Product Engineering group, the engineer shall support product development, process development, and manufacturing activities involving the combination product. Under direction from more senior team members, the employee shall utilize R&D methods and engineering techniques to develop processes, generate test systems, and improve manufacturing procedures with respect to the combination product manufacturing line. With guidance, the engineer shall write and execute engineering protocols, document reports, and all elements necessary to launch combination products through design control. The engineer shall also provide support for special projects involving modifications to the combination product and subsequent pre-clinical and clinical rollout.

• Ability to design, develop, test and refine cost-effective device or combination product prototypes to enable in vitro and in vivo testing
• Must be skilled in understanding complex scientific problems and experimental hurdles, and in solving them.
• Must have hands-on-experience working with and developing experimental systems, prototypes, test equipment, etc.
• Experience developing systems for aseptic processes and clean room environments.
• Knowledge of quality systems for medical devices (ISO 13485 and FDA QSR)
• Knowledge of Cell Culture and Aseptic Technique.
• Strong CAD skills, experience with SolidWorks is a plus
• Strong verbal and written communication skills with the ability to summarize and communicate scientific results effectively is required.
• Self-starter with ability to be productive with limited oversight.

Requirements

B.S. or M.S. in chemical, mechanical, material or biomedical engineering, or related field is required. One year of work experience in medical device or combination product research or manufacturing is preferred.

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 2020-04 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 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.

• Strong verbal and written communication skills are required. Must be able to summarize and communicate technical concepts effectively.
• Must possess fundamental and applied knowledge related to engineering principles and material science
• Must be skilled in identifying complex scientific problems and experimental hurdles, and in solving those problems.
• Hands-on prototyping and process development experience preferred.
• 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.

Requirements

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 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.