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

This position will focus on quality control activities supporting the manufacture of therapeutic cell products, implantable devices, and cell therapy combination products.

We are currently seeking a QC associate to work in both laboratory and cleanroom environments under strict SOP’s for performing environmental monitoring.  Responsibilities include; sampling using EM equipment, sample handling, reporting results with accurate documentation, maintaining database of results, investigation of OOS’s, and determination of root cause as appropriate.

Other responsibilities include quality review and release of all incoming GMP materials; Inventory control management and preventative maintenance activities. Raw material, In-process and lot release sample handling, testing and tracking.  Assisting with other duties as needed.

A hands-on approach is required for most job tasks, such as environmental monitoring.  Knowledge and experience with aseptic technique is required.  The ideal candidate is self motivated, detail oriented, resourceful, flexible and able to handle multiple priorities at once.  Flexibility to handle shifts in manufacturing schedules is essential.  Weekend work will be required due to the biological nature of the products.

Primary requirements/duties

1. Adhere to all company policies, quality policies, and SOPs.
2. Perform Environmental monitoring.
3. EM sample handling.
4. Report results and database management.
5. Receiving activities for GMP supplies/materials-including proper documentation review, and disposition.
6. Quarantine and storage of materials as required.
7. In- process and release test sample handling, testing and tracking.
8. Raw material sample handling, testing and tracking.
9. Inventory control of retains/ raw materials and other QC materials.
10. Assist with purchasing general supplies and EM supplies.
11. Responsible for preventative maintenance general upkeep of the QC EM equipment and areas.
12. Perform other duties as assigned.

Requirements

• Minimum of 3 years working experience in quality control or environmental monitoring in a biotechnology or pharmaceutical company.
• Experience in an aseptic manufacturing clean room
• College degree in a scientific discipline
• Experience in handling of biological/raw materials.
• Ability to work well in a team environment
• Strong written and oral communication skills
• Excellent record keeping skills and attention to detail
• Must be skilled in Microsoft Windows and Office, including Word and Excel.

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.

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 2019-13 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

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 2019-15 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 team member of the Device Manufacturing group, incumbent will perform a broad scope of work tasks in an ISO 13485 compliant manufacturing area to generate combination drug products for use in clinical and development studies. Associate shall also perform various industrial quality control testing and inspection for raw materials and manufactured products as well as support the ongoing development activities lead by Engineering. Assigned tasks will be conducted in both routine and non-routine conditions and expected to be performed with minimal oversight. Department operation is considered moderate-paced in work flow and necessitates adaptation to intermittent work fluctuation and exigency in business needs. This position is for full time, day time (1st shift) position, Monday thru Friday and may require occasional overtime per demand.

• Assemble implantable combination drug product devices in a non-aseptic clean room environment according to manufacturing standard operating procedures (SOP) and other controlled documentation.
• Perform an assortment of activities in a manufacturing production line fashion by converting raw materials into finished goods and conducting inspections per design specification. Perform packaging and distribution of in-process and final products.
• Support the execution of product design verification testing, assist with equipment qualification protocols, recording data results, and collaborate with Engineering to support device manufacturing related requests.
• Follow and execute production batch records via cGMP processes.
• Execute and record routine preventative maintenance for controlled equipment used throughout the device manufacturing area. Assist with logistics for controlled equipment calibration and metrology vendors.
• Liaise with Materials Management and Quality Control departments to request inventory-controlled material pulls through prepared inventory requisitions. Perform incoming material receiving duties per part specification, and assist with orderliness of the device manufacture storage warehouse area.
• Support composition and revision to SOPs, batch records and other controlled documents applicable to device manufacturing as needed.
• Aid in identifying and implementing continuous improvements to the device manufacturing department through lean manufacturing strategies where applicable.

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-path deadlines. Flexibility to handle rapidly changing objectives and timelines is essential.

Requirements

A high school diploma is required. Minimum of 5 years work experience with at least 2+ years in medical device manufacturing or in a similar production environment is required. Must be able to compose and communicate in English.

• Experience with operating manual and semi-automated manufacturing equipment using gross and fine motor skills are required.
• Expected to display Good Manufacturing Practice (GMP) documentation habits and workmanship in a manufacturing environment according to SOPs or directed work instructions.
• Ability to identify, distinguish and judge product defects and process anomalies as well as follow product drawing schematics per specification.
• Ability to follow, train, review and revise manufacturing SOPs and batch records through change control management systems.
• ISO class cleanroom operating experience is preferred.
• Excellent verbal and written communication skills are required. Must be able to communicate effectively across multiple audiences in a professional demeanor.
• Ability to adapt and handle multiple and simultaneous assigned tasks in a flexible manufacturing system setting with limited management.
• Knowledge of quality systems for medical devices (ISO 13485 and FDA QSR) is preferred.
• Familiarity and use of Kanban, Kaizen, 5S and other lean manufacturing principles is highly desirable.

An equivalent combination of education and industry work 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 2019-17 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 Trial Assistant will coordinate and supervise various aspects of clinical studies.  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 trials as assigned.
• Provide general support to the Clinical Trial Manager (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 organizations (CROs) 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 and perform 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 (i.e., GoToMeeting, Webex, etc.) 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.

Requirements

A college degree in a biological or engineering science is required.  A minimum of one year of work-related clinical research industry experience is preferred.  An equivalent combination of education and experience to successfully perform the job duties listed above is acceptable.

• Excellent teamwork, decision-making and organizational skills are required.
• Working knowledge GCP, Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements is necessary.
• Must be able to prioritize multiple tasks.
• Must be skilled in Microsoft Office, including Word, Excel, and PowerPoint.
• 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 a computer screen; and hearing and speech to communicate in person and over the telephone.
• Stamina as required for business travel.

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 #2020-01 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.