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.

Company Overview

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

Position Description

The HR Specialist role is to provide comprehensive Human Resources (HR) support and facilitate the day-to-day responsibilities of the HR department including, but not limited to: recruitment, hiring/onboarding, benefits, leaves of absence, employee relations, compliance, maintaining HR systems and maintaining and enforcing company policies and procedures as well as performing data entry and reporting.

• Serve as first line of contact to employees and managers on questions relating to HR systems, policies and procedures.
• Maintain personnel files in accordance with applicable labor law requirements and record retention best practices. Owner of HRIS system and personnel records.
• Partner with employees and supervisors to ensure job descriptions are regularly updated, and goals and performance related documents are submitted and on file.
• Facilitate recruitment process, including but not limited to: writing and posting job advertisements, gathering, screening and forwarding resumes, scheduling interviews, checking references, processing background checks and maintaining applicant files. Coordinate training with hiring managers and interviewers, as needed, to ensure consistent, fair and effective candidate selection and interview process.
• Build and organize onboarding activities, including new hire orientation, company overview meetings and training activities in collaboration with hiring manager and HR Manager.
• Partner with HR Manager to respond and assist with employee relations matters and investigations.
• Responsible for day-to-day benefits support activities, including, but not limited to: assisting employees with questions and resolution of benefits matters, processing participant enrollments, changes, and terminations, verifying and approving invoices for payment and completing periodic compliance reports.
• Lead annual evaluation of benefit plan design and pricing, including arranging renewal meetings, preparing cost and coverage analyses, providing recommendations and facilitating final plan selections.
• Coordinate open enrollment activities for benefits programs, such as preparing census data, scheduling meetings, compiling benefit materials, communicating logistics and deadlines to employees, and educating employees on plan designs and selections.
• Coordinate administration of 401(k) plan, including but not limited to: processing enrollments, changes, terminations, and 401(k) loans, arranging financial education seminars, coordinating investment committee meetings, complying with periodic disclosure requirements and assisting with other compliance tasks.
• Administer and oversee disability/workers compensation claims and leave of absence programs, including but not limited to: processing forms, verifying and coordinating appropriate salary adjustments with payroll, and working with case managers and employee claimants to ensure proper compliance and accurate compensation.
• Maintain organizational charts and HRIS system, including full-cycle processing of employee census data updates such as hires, separations, transfers, compensation adjustments, and other personnel information changes, with a high level of accuracy.
• Maintain effective system of communication/notification, and work jointly with payroll accountant to ensure any changes affecting employees (new hires, terminations, calculation of pay adjustments, benefit enrollments, leaves of absence, etc.) are processed timely and accurately.
• Conducts or assists with record audits, mandatory reporting, and/or various HR surveys which may include I-9 audits, EEO-1 filings, ACA reporting, compensation and/or benefit surveys, workers compensation and payroll audits, and other compliance reviews.
• Provide HR system(s) support for employees including, time-keeping, navigational questions, and basic system usage (i.e. self-service).
• Assist with updating any HR policies, procedures and processes that support business needs and objectives. Identifies opportunities to clarify existing policies and improve any existing procedures and/or systems in line with company needs.
• Participate and/or assist with events and activities to enhance employee relations.
• Perform other related duties as required and assigned.

Requirements

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

• Experience with HR system(s) implementation a plus.
• HR certification and active affiliation with appropriate Human Resources networks and organizations is a plus.
• Thorough working knowledge of applicable employment-related laws and regulations for state, federal and/or local jurisdictions.
• Ability to work independently and proactively, with minimal instruction and supervision, while working in a fast-paced environment with multiple deadlines and frequently changing priorities.
• Superior oral, written, and interpersonal skills including ability to communicate effectively with people individually and in large groups.
• Independent thinker with excellent organizational skills, with solid follow-up and follow-through and strong attention to detail.
• Excellent time management skills with a proven ability to consistently deliver quality work and meet deadlines.
• Ability to perform duties with integrity, professionalism, and confidentiality.
• Ability to maintain and build strong work relationships and actively seek opportunities to influence, build trust and gain alignment with peers, functional leaders and/or external partners to accomplish tasks and business objectives.
• Strong analytical, critical thinking, mathematical, planning and problem-solving skills.
• Proficient with Microsoft Office Suite and proficiency with and/or the ability to quickly learn the organization’s HRIS and/or other HR related software and systems.

Application Procedure

For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2019-21 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 Facilities group, incumbent will perform a broad range of tasks in the support of Clinical Manufacturing, Device Manufacturing, and R&D operations at two facilities. Assigned tasks are expected to be routine in nature and performed with a minimal amount of oversight.  This is a full-time day shift position.

• Monitor and respond to alarm calls after and during regular working hours.
• Knowledge of cGMP’s and implementation during daily activities.
• Obtain and maintain aseptic gowning qualification.
• Basic Knowledge of lab equipment such as centrifuges, incubators, lab water systems, autoclaves, and glasswashers.
• Ability to perform general facilities functions such as painting, flooring, door repairs, office setups, and equipment relocations.
• Assist in Validation of Utilities and Equipment as needed.
• Performing duties consistent with a facilities coordinator on a limited basis.
• Schedule, perform, and document routine equipment preventative maintenance.
• Identify and implement improvements to facilities processes.
• Cooperate and coordinate with outside departments as needed.
• Respond to requests for unscheduled services and maintenance activities
• Coordinate and oversee work of third-party vendors supporting facilities projects. Including calibration, equipment and construction vendors.
• Candidate must be able to read and understand schematics, blue print and PID’s
• Must have basic computer and organizational skills.
• Must have the ability to communicate clearly in oral and written communications.
• Must capable of working on mechanical and plumbing systems.
• Knowledge of general electrical and electrical safety is desired.

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

Requirements

A high school diploma is required. A minimum of two years in the medical device manufacturing or pharmaceutical/biotech production environment is preferred.

Trade or vocational school certificate 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 2019-22 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 administrative team.  The Executive Administrative Assistant will perform a variety of tasks in a busy corporate office in collaboration with other team members.  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.  Ideal candidates enjoy working in an administrative role with a variety of routine and non-routine responsibilities in support of both internal and external customers, and thrives where the impact of individual success and collective success are equally valued.

General duties will include:

• Provide executive assistance to vice presidents.
• Arrange and monitor travel plans for employees, visitors, and consultants in accordance with current company policy.
• Coordinate conferences, company meetings, and guest visits, including agendas, room set up, refreshments, teleconference instructions, and audio-visual equipment.
• Coordinate a variety of administrative and office-related vendor services.
• Manage and stock office supplies and maintain organized workspaces in the administrative office, lunchroom, and conference rooms.
• Perform front office duties, such as greeting guests, answering phones, sorting and sending mail and packages, and maintaining corporate calendar of events and employee directory.
• Maintain calendar of recurring and upcoming tasks to organize and complete related administrative matters timely and proactively.
• Provide administrative support to accounts payable and human resources as needed.
• Performs complex administrative activities including managing projects, composing letters and reports, and preparing/editing presentations, which are sometimes confidential in nature.

Job Requirements

• Bachelor’s degree and 6 years of experience as a front office administrator or executive assistant; an equivalent combination of education and experience may be considered
• Strong command of standard, professional office practices and procedures
• Highly proficient in MS Office and a resourceful, quick learner of other software programs and tools
• Excellent communication and interpersonal skills and ability to provide information and service to a wide range of internal and external contacts
• Keen attention to detail and quality of work and service caliber
• Ability to make sound judgments and to creatively solve problems in a fast-paced, growing environment
• Proactive and service-oriented with thoughtful follow-through on assigned tasks
• Must possess mobility to work in a standard office setting and to use standard office equipment; stamina to maintain attention to detail despite interruptions; strength to lift and carry office supplies, files and refreshments weighing up to 10 pounds
• Work experience in the biotechnology industry is strongly preferred

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 #2019-Admin 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.