Careers at ViaCyte

Position Description

Perform experiments and analyses related to culture of human pluripotent stem cells and development of a cell therapy product.

This is a full-time position located in San Diego, CA and is not eligible for relocation at this time

Essential Duties & Responsibilities

• Grow, passage, and differentiate human pluripotent stem cells using aseptic technique including protocol optimization.
• Analyze the progression of cell differentiation in vitro using real time gene expression using Nanostring platform.
• Executes, and interprets experiments, with a high degree of reliability.
• Conducts own experimental troubleshooting on routine problems.
• Performs basic statistical analysis of experimental data, where appropriate.
• Prepares protocols and written study reports.
• Surveys relevant scientific literature to maintain awareness of issues and trends within the field.
• Present studies effectively at internal Group/Department or Project Team research meetings.
• Performs other duties as assigned.
• Highly self-motivated and flexibility in working schedule to accommodate weekend work when necessary.

Experience Required

• Extensive Embryonic stem cell culture experience is required.
• Knowledge of stem cell biology and/or developmental biology is preferred.
• Experience with molecular biology techniques especially Nanostring, viability, cell death assays and ELISA is required.
• Must have demonstrated the ability and willingness to perform a wide variety of tasks – from those which are routine in nature to those which require independent thought and analysis.
• Must be skilled in the Windows operating system and Microsoft Office, primarily Word, Excel and PowerPoint.
• Strong verbal and written communication skills are required.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

Education

• A master’s degree in cell biology or a related field, and a minimum of five years of laboratory experience is required.
• 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: 2021 – 53 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify Employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.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 analyst in this position will perform a broad range of activities to characterize and release stem cell derived pancreatic cells for in vitro, preclinical, and clinical studies. Responsibilities include the analytical characterization of differentiated cells using qualified assays for cell proliferation, differentiation, and gene expression.

This is a full-time position located in San Diego, CA and is not eligible for relocation at this time

Essential Duties & Responsibilities

• Perform testing of routine and non-routine samples, and document according to GMP.
• Participate in assay control testing, lot to lot antibody release, and product stability testing.
• Analyze data, report results, and advise internal customers regarding outcomes of testing.
• Write SOPs and reports as needed.
• Maintain equipment and instrumentation to comply with GMP guidelines. Monitor instrument performance to assure optimal operation. Assist with calibration, documentation, ordering and tracking of materials
• Support internal audits.
• Actively participate in the development and/or optimization of analytical methods.

Experience/Knowledge/Abilities:

• Demonstrated experience with aseptic cell culture methods, including cryopreserving, thawing and culturing cell lines is essential.
• Experience with cell-based assays (gene expression, flow cytometry, ELISA) is essential.
• Experience performing testing in a regulated laboratory environment (cGMP, cGLP, clinical lab scientist) is essential.
• Ability and willingness to perform a wide variety of tasks – from those which are routine in nature to those which require independent thought and analysis.
• Must be highly detail oriented, maintain accurate records, perform data analysis and communicate results through written and oral summaries.
• Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel.
• Strong verbal and written communication skills are required.

Required Qualifications:

• BS/MS in cell or molecular biology and a minimum of 3 years of laboratory experience is highly desirable
• 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: 2021-63 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify Employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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

ViaCyte is seeking a highly motivated and talented individual to join the Process Development (PD) team in developing commercial production processes for a cell-based therapy to treat diabetes. This position is open to individuals that have experience supporting cell & gene therapy bioprocessing efforts at either cell therapy process engineer I, II, or senior levels. Under minimal supervision, the primary activities of the Cell Therapy Process Engineer will be to provide process science and engineering support for commercial GMP technology transfers, development studies, and continuous improvement projects for ViaCyte’s human embryonic stem cell (hESC) based cell therapy products. Additional activities include design-of-experiments (DOE), lab management, data entry, writing of technical reports, and support of other cross-functional projects.

This is a full-time position located in San Diego, CA.

Essential Duties & Responsibilities

1. Execute hESC and hESC-derived culture and analytical experiments under written protocols. hESC/hESC-derived culture will be performed using multiple platforms at multiple scales (e.g. multi-layer cell factories, roller bottles, bioreactors, etc.). Assay methods include, but are not limited to, design-of-experiments (DOE), flow cytometry, expression profiling, ELISA, and metabolite analysis.
2. Lead continuous improvement initiatives with high complexity and impact to ViaCyte’s cell drug substance manufacturing paradigm.
3. Participate in the evaluation of new technology (closed processing and process automation) for introduction into GMP cell drug substance manufacturing.
4. Design studies, author protocols and reports for process characterization studies for the growth and differentiation of hESCs.
5. Provide technical leadership by acting as a communication channel between cross-functional groups, company operations, and external partners.
6. Perform cleaning and maintenance activities required to ensure a contamination-free environment.
7. Support general laboratory and equipment maintenance as required.

Required Qualifications:

• BS/MS degree that included laboratory work in a Chemical Engineering, Mechanical Engineering, Biomedical Engineering or related field. Two to five years of laboratory experience in an academic, biotechnology, or pharmaceutical setting is preferred.
• Experience with mammalian cell culture and/or in a cGMP manufacturing/laboratory environment preferred.
• Experience with design-of-experiments (DOE), process design of scalable cell processing, media formulation, and bioreactor technologies.
• Experience with computational modeling platforms for process parameter prediction (e.g. fluid dynamics, mass transfer)
• Proficiency in cell culture aseptic techniques is required.
• Must have a flexible schedule and be able to work some weekends and holidays.
• Ability to work independently and as a team member.
• Ability to follow detailed instructions and to maintain detailed and accurate records and notes.
• Ability to successfully perform multiple tasks and changing priorities, when required.
• Skill in problem solving and troubleshooting.
• Ability to safely operate production equipment in accordance with established practices.
• Must be skilled in the Windows operating system and Microsoft Office, including Word and Excel, imaging and illustrating software, and specialized applications in use in the laboratory (e.g. JMP).
• Strong verbal and written communication skills are required.
• Willingness to learn and contribute, with a team-oriented attitude.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.
• Equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Preferred Qualifications: 

The ideal candidate will have engineering experience with a cell and gene therapy bioproduction focus and will be technically strong and adept at managing multiple priorities. Our business moves at a rapid pace, making resourcefulness and flexibility key contributors to success.

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: 2021-64 and your full name.  Send to careers@viacyte.com.  Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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 Regulatory Affairs Manager will contribute to successful achievement of ViaCyte’s product development objectives through managing, evaluating and completing regulatory projects consistent with established timelines and goals. They will be responsible for the development and implementation of regulatory submission plans, authoring submissions, performing regulatory operations activities, and maintaining the regulatory files. The Regulatory Affairs Manager will provide assessments of product and process changes, and collaborate with development teams, peers and management with a positive constructive attitude in communications to inspire cooperation and teamwork.

This is a full-time position located in San Diego, CA.

Essential Duties & Responsibilities

• Author and submit routine submissions to Global Authorities and EU Legal Representative
• Assist in the development of Regulatory Submission Plans and timelines
• Assist in the authoring and review of moderate to complex regulatory submissions and associated support documentation
• Review change controls and provide impact assessments for minor changes
• Perform regulatory operations activities
• Maintain regulatory submission and correspondence files
• Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures
• Other duties as assigned

Required Qualifications:

• Bachelor’s degree in scientific discipline
• 2-5 years’ experience in pharmaceutical, medical device or biologics industry
• Minimum of two (2) years of experience in regulatory affairs
• Experience and knowledge in preparation of INDs, CTAs and supportive amendments and supplements (manufacturing, nonclinical, clinical) including experience with CTD/eCTD
• Working knowledge of FDA and ICH regulatory guidance and regulations
• Equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable

Preferred Qualifications: 

• Regulatory experience with drug/device or biologic/device combination products

• Experience in the Biologics or Biotech industry, ideally with Advanced Therapy products
• Working knowledge of Regulatory Operations and CTD/eCTD standards

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: 2021-71 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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 Facilities group, incumbent will perform a broad range of tasks in the support of Clinical Manufacturing, Device Manufacturing, and R&D operations at all ViaCyte facilities. Assigned tasks are expected to be routine in nature and performed with a minimal amount of oversight.

This is a full-time position located in San Diego, CA.

Essential Duties & Responsibilities

• Direct all facility related activities including building maintenance and improvement, environmental health and safety, validation support, security, and materials management support.  This may include management of multiple groups and staff.
• Complete GMP documentation as required for equipment and facility systems.
• Work in conjunction with Quality, Manufacturing and other functions to implement best practices, process improvements and to support audits.

• Ensure that facilities, utilities and equipment meet company needs and comply with government regulations and environmental, health and security standards.
• Be part of a rotating on call strategy to support MFG and R&D 24/7/365 operations.
• Must be skilled in troubleshooting mechanical, utilities and electrical problems and driving solutions to resolution in short timeframes.
• Must have hands-on practical experience with facilities and equipment maintenance and repair including cleanroom spaces.
• Must be satisfactorily skilled in Microsoft Office, including Word and Excel, Outlook, and demonstrate basic competence in working with electronic database software.
• Preference for candidates who have worked in a regulated (ISO, GMP, EMEA) industry where facilities and equipment must meet defined operational criteria with associated requirements for maintaining compliance documentation.
• Experience performing work in clean rooms preferred.

Required Qualifications:

• A high school diploma is required. A minimum of two years in the medical device manufacturing or pharmaceutical/biotech production environment is preferred.
• Additional certifications or training as applicable to this position
• Trade or vocational school certificate preferred / Equivalent military training.
• 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: 2021-72 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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

Provides executive level administrative support to the Chief Science Officer (CSO), Head of Business Development, Head of Legal and other departments as needed.  Handles matters with strict confidentiality and meets short deadlines and manages priorities. Focus areas of work may vary based on individual needs of the manager and functional area.

This is a full-time position located in San Diego, CA.

Essential Duties & Responsibilities

• Provide executive support to three executives: Chief Scientific Officer, Head of Business Development, and Head of Legal to manage their time and coordinate requests including managing calendars that require a high level of coordination, attention to detail and sensitivity.
• Plan, organize, schedule and coordinate meetings and events with individuals or large groups including coordinating conferences, company meetings and guest visits, managing and setting agendas, research and recommendations on locations, room set up, refreshments, conference call dial-in instructions and audio-visual equipment.
• Answer, screen, respond and route calls independently when appropriate and in a manner that is professional, and is a positive reflection of the company.
• Prepare documents, meeting agendas, meeting minutes, presentations and spreadsheets
• Make travel arrangements and prepare itineraries for travel within the U.S. and internationally; change travel schedules, flights, hotels and rental cars.
• Review, compile and process business expense reports.
• Provide other general administrative support including, mail, filing, scanning, copying, etc.
• Collaborate with other company Executive Assistants and provide backup assistance to ensure seamless and high-quality level of support services for office & administrative needs throughout the organization.
• Other duties as assigned.
• Strong command of standard, professional office practices and procedures.
• Demonstrated experience managing multiple complex calendars for executives.
• Extensive experience in the planning, coordination, and execution of various types and sizes of meetings and events.
• Highly proficient with MS Office with ability to quickly learn and utilize various software applications to complete assigned tasks.
• Ability to make sound judgments and problem-solve creatively, resourcefully and nimbly in a fast-paced, changing environment.
• Clear and professional written and verbal communication skills.
• High attention to detail and quality of work, including thorough consideration for its method of delivery to end users.
• Strong sense for upholding confidentiality over various corporate, HR and other sensitive materials and data encountered during the course of work.
• Proactive, positive and customer service-oriented with thoughtful follow-through.

Required Qualifications:

• Bachelor’s degree or formal training and certification from a community or technical college in office management, executive assistant skills, or related field.
• Minimum of six years’ experience as an office administrator or executive assistant.
• 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: 2021-74 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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 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 located in San Diego, CA.

Essential Duties & Responsibilities

• Maintains or leads 3-5 study databases and data management activities concurrently
• Independently performs all data management activities, including but not limited to database development, edit check programming, testing, validation, site training and support, query resolution, audit, lock, and archive.
• Develops and enforces Standard Operating Procedures (SOPs) and procedures with oversight of Director of Data Management
• Administers technical Data Management (DM) applications, users accounts, and access levels required to manage clinical data.
• Assists in creating CRF design standards
• Serves as liaison to core team for data quality updates and clinical data management related issues.
• Develops study specific documents such as Data Management Plan(DMP), Case Report Forms(CRFs), CRF Completions Guidelines(CCGs), User Acceptance Testing(UAT) plan.
• Develops and reviews Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
• Provides management and oversight of vendor data including collection, QC, and archival.
• Responsible to work directly with Clinical Research Organizations (CROs) in the development and management of Clinical Studies; including review data for quality, review and provide feedback for DM related documents.
• Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
• Receipt and archive of clinical trial data and/or data management documentation
• Responsible to coordinate coding for adverse events and concomitant medications
• Ensure quality of clinical data within EDC prior to lock and freeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
• Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
• Perform all DM responsibilities in accordance with company guidelines and SOPs and appropriate industry and regulatory standards and Good Clinical Practices.
• 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.
• Experience in managing CROs and vendor data
• Experience in performing MedDRA and/or WHO coding
• Experience building EDC in various platforms, preferred knowledge of Medrio, Rave, Veeva.
• 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.
• Preferred knowledge of SQL, SAS programming, JReview
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

Required Qualifications:

• BA or BS in a life science, computer science, or related fields
• Minimum 5 years of experience in Data Management within the pharmaceutical/biotech industry
• Minimum 1 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
• 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: 2021-75 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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

You are a highly motivated and talented contributor and looking to join an exciting and fast-growing company to develop cell therapeutics and product platforms. You will have significant research experience in the development of differentiation protocols for stem cell derived cell therapies and their evaluation in animal models. You are skilled in the development and small-scale manufacture of gene-edited cell therapy products. experience with molecular biology, assay development, and pancreatic developmental and islet biology. You demonstrate the ability to dissect challenging problems, interact effectively with team members, and manage multiple priorities in-parallel.

This is a full-time position located in San Diego, CA. The position will be 100% on-site, and requires flexibility in working schedule to accommodate weekend work when necessary

Essential Duties & Responsibilities

• Gene-editing using CRISPR/Cas9 in human pluripotent stem cells (PSCs, including ESCs and iPSCs) and generate seedbanks from selected clones using aseptic techniques.
• Grow, passage, and differentiate human pluripotent stem cells using aseptic technique and multiple small-scale manufacturing platforms. Adjust the differentiation protocol to optimize the cellular product.
• Analyze the progression of cell differentiation in vitro using real time gene expression using Nanostring platform and other assays.
• Execute, and interpret experiments, with a high degree of reliability.
• Conduct own experimental troubleshooting on routine problems.
• Perform basic statistical analysis of experimental data, where appropriate.
• Prepare protocols and written study reports.
• Survey relevant scientific literature to maintain awareness of issues and trends within the field.
• Present studies effectively at internal group, department or project team research meetings.
• Highly self-motivated and flexibility in working schedule to accommodate weekend work when necessary.
• Flexibility to handle rapidly changing objectives and timelines is essential.
• Extensive embryonic stem cell culture and gene-editing experience is required.
• Knowledge of stem cell biology and/or developmental biology is preferred.
• Experience with molecular biology techniques especially Nanostring, viability, cell death assays and ELISA is required.
• Must have demonstrated the ability and willingness to perform a wide variety of tasks – from those which are routine in nature to those which require independent thought and analysis.
• Must be skilled in the Windows operating system and Microsoft Office, primarily Word, Excel and PowerPoint.
• Strong verbal and written communication skills are required.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

Required Qualifications:

• A bachelor’s degree in cell biology or a related field, and a minimum of five years of laboratory experience is required.
• 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: 2021-76 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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

You are a highly motivated and talented contributor and you are looking to join an exciting and fast-growing company to develop cell therapeutics and product platforms. You will have significant research and team-leadership experience in the development of differentiation protocols for stem cell derived cell therapies and their evaluation in animal models. You are skilled in the development and small-scale manufacture of gene-edited cell therapy products. It would be a plus if you have experience with molecular biology, assay development, and pancreatic developmental and islet biology. The position requires the ability to dissect challenging multi-faceted problems, interact effectively with team members cross-functionally, and manage junior scientists and associates.

This is a full-time position located in San Diego, CA. The position will be 100% on-site, and requires flexibility in working schedule to accommodate weekend work when necessary.

Essential Duties & Responsibilities

• Gene-editing using CRISPR/Cas9 in human pluripotent stem cells (PSCs, including ESCs and iPSCs) and generate seedbanks from selected clones using aseptic techniques.
• Establish robust protocols to generate the scalable differentiation of various specific cell types from stem cells.
• Coordinate experiments and projects collaboratively with R&D/engineering/scale-up teams internally and with external service contract organizations.
• Demonstrate decision-making, initiative, innovation and leadership in the growth, passage, and differentiation of gene-edited human pluripotent stem cells.
• Maintain detailed documentation records and author reports, SOPs, batch records and other materials to facilitate new product feasibility.
• Execute, and interpret experiments, with a high degree of reliability.
• Demonstrate scientific proficiency at an advanced level, specifically a familiarity with relevant scientific literature to find novel solutions to cell therapy problems.
• Foster communication and collaborative teamwork. Supervise or mentor junior personnel.
• Highly self-motivated and flexibility in working schedule to accommodate weekend work when necessary.
• Flexibility to handle rapidly changing objectives and timelines is essential.
• Proven expertise in developing human stem cell approaches, applications to unique biological problems, and differentiation protocol development.
• A track record of managing junior scientists for gene-edited human PSC cell culture, characterization, quality control, and differentiation.
• Highly organized, scientifically rigorous with a significant attention to detail.
• Knowledge of stem cell biology, developmental biology and/or animal models is preferred.
• Proven hands-on experience with relevant cell-based and molecular biology readout techniques (e.g. Nanostring, RNA-Sequencing, FACS, immunostaining, viability, cell death assays, ELISA, among others).
• Must have demonstrated the ability to be self-driven, independently motivated, data-driven and an excellent problem-solver.
• Must be skilled in the Windows operating system and Microsoft Office, primarily Word, Excel and PowerPoint.
• Strong verbal and written communication skills are required.
• Ability to work independently as well as collaborate with peers and effectively work in a results-oriented research team environment.
• Must possess experience, knowledge, and abilities necessary to perform the essential duties listed in the previous section.

Required Qualifications:

• D. in molecular and cell biology, developmental biology, stem cell biology, or related disciplines and a minimum of three (3) years of relevant post-doctoral employment experience.
• 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: 2021-77 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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

Associate will organize, lead 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 located in San Diego, CA.

Essential Duties & Responsibilities

• Organize material logistics and manufacturing operations to produce GMP grade product to meet corporate goals.
• Coordinate and ensure sufficient materials are available for all production runs or campaigns including media, small molecules, and growth factors.
• Support material release testing as needed.
• Coordinate, provide guidance and hands on support for scale out/up and development activities as needed based on a demand plan.
• Convert manufacturing practices into written SOPs and batch records.
• Coordinate and provide guidance and technical training to lower level personnel.
• Lead collaborative efforts with team members in the identification and implementation of continuous improvement initiatives.
• Design, execute, and report on experiments intended to improve Cell Manufacturing processes.
• 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 areas 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.
• Ensure timely review of Batch Records.
• Work with subject matter experts to troubleshoot and or optimize processes as required.
• Assist in preparing/conducting technical presentations of manufacturing processes.
• Experience culturing human embryonic stem cells is preferred.
• Current knowledge and understanding of GMP principles and requirements as applied to the biotechnology manufacturing industry is preferred.
• Ability to effectively coordinate department activities with different functional groups within the manufacturing and operations departments.

• The ability to perform some weekend work is required.
• Must be skilled in Microsoft Office, including Word, Excel, and PowerPoint.
• Good verbal and written communication skills are preferred. Must be able to write and speak effectively across multiple departments/disciplines.

Required Qualifications:

• A college degree in a biological or engineering science is required.
• Minimum of 5 years of experience in cell culture-based manufacturing or development operations is preferred.
• A minimum of 1 years’ experience in a GMP manufacturing environment is required.
• 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: 2021-78 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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

Position is responsible for completing the physical and systematic movement of materials in accordance with all safety, cGMP, and quality procedures. Material Handler will be cross trained in a variety of warehouse functions including but not limited to receiving, shipping, and inventory control to support Manufacturing, R&D, and Product Development in a multi-warehouse/multi-site environment. Position is expected to transact all material transactions in a timely manner and maintain all required documents for material movement as per quality procedures.

This is a full-time position located in San Diego, CA.

Essential Duties & Responsibilities

• Be cross trained in all warehousing activities including but not limited to receiving, shipping, manufacturing support, and inventory control in compliance with Quality Standard Operating Procedures
• Able to obtain and/or has been certified on multiple types of material handling equipment
• Pull/pick inventory for manufacturing
• Manage the inter-departmental transport of materials
• Create and maintain inter-departmental material transfer documentation
• Assist in cycle count activities
• Perform receipt and inspection of incoming materials as needed
• Manage item disposition per QC status in warehouse
• Perform product inspections against purchase order
• Fulfill material request following First in First out method
• Maintain a clean and safe working environment
• Ability to lift 60 Pounds.

Required Qualifications:

• High School diploma or equivalent
• 1+ years of experience in material management from a biotech or life science industry preferred but not required
• Strong written and verbal English communication skills
• Strong mathematical and problem-solving skills
• Understanding of Microsoft Office
• Valid California Driver’s License
• DMVR clean record
• Equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

Preferred Qualifications: 

• Forklift certification a plus, but can be trained
• IATA training and experience is preferred

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: 2021-79 and your full name.  Send to careers@viacyte.com. Our mailing address:  ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121. We are an E-Verify employer.

Policy

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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.