GMP Technical Operations Associate Scientist/Engineer I
This position is responsible for assisting the Director of GMP Bioprocess Technical Manufacturing Operations for the Duke Human Vaccine Institute (DHVI) to develop, implement and oversee tech transfer deliverables; cGMP cell bank, drug substance, and drug product clinical manufacturing; and manage execution of release requirements for early phase materials for use in human clinical trials of HIV-1 and other infectious disease candidate vaccines. This position will be responsible for execution of various aspects of multiple cGMP campaigns.
- Provides hands-on support and execution for cGMP campaigns, including authoring of batch documents for execution of unit operations, documenting all steps of the process and materials used for campaigns, deviation investigation report authorship for complex upstream and downstream equipment / facility / system events.
- Collaborates closely with development teams to provide support for development activities and works to learn the technical details of unit operations unique to each process under development.
- Maintains all materials required for cGMP production, including working with vendors to meet DHVI shipping/delivery/documentation needs, performs investigations which include contributions to detailed reports, assistance in compiling trends/risks/and recommendations to wider cGMP team / Quality, and negotiates pricing. Maintains cGMP equipment and facilities on a daily/weekly/monthly/quarterly basis, including working with vendors to meet DHVI calibration/repair/documentation needs, performs investigations, and negotiates pricing. Assists with the compilation of quotations for grant and contract applications, for cGMP facility materials / components / equipment / and services.
- Writes and reviews technical reports; writes protocols for tech transfer and SOPs for cGMP production, and presents data to project teams / external stakeholders.
- Provides start-up assistance, including commissioning / qualification / protocol documentation ownership and support, for cGMP facilities for equipment items, such as sterile tubing welders, CTUs, and filter integrity testers. Manages timelines and all deliverables included in this scope, such as SOP authorship, calibration requirements, tracking of issues/resolution, and turnover change control documentation closure.
- Designs experiments, executes and documents cGMP activities in compliance with regulatory requirements.
- Compiles data, performs analysis / interpretation, and draws conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarizes data, presents results and proposes next steps to advance the cGMP program.
- Performs root cause analysis for all investigations and implements robust corrective actions in a timely manner. Uses good documentation practices for all records, adhering to SOPs, and performing self-audits to ensure compliance. Trains the broader cGMP team on proper documentation practices and acceptable corrective actions for a cGMP compliant organization.
- Perform other related duties as necessary and requested by GMP leadership.
You must be willing and available to work flexible hours which may include later start and end times with the understanding that work hours may need to be extended until a project/task has reached a logical and acceptable stopping point to maintain the integrity of the process.
- Preferred experience that include the following:
- cGMP Vaccine and/or Biologics manufacturing experience (clinical manufacturing and/or licensed product manufacturing)
- Experience with cGMP Cell Banks and/or Drug Substance and/or Drug Product manufacturing (clinical manufacturing and/or licensed product manufacturing)
- Solid understanding of cGMP regulations for Vaccines and/or Biologics
- GDP experience in an agency-regulated manufacturing environment
- Experience authoring and/or approving controlled documents
- cGMP Facility and/or equipment start-up experience
- Direct experience working with third-party vendors
- Master’s degree is a plus
- Must be self-motivated, detail-oriented, well organized, approach procedures with critical thinking of the technical aspects with strong communication skills and ability to work in an interactive team environment.
- Must have the ability to problem solve and operate independently, yet escalate when necessary
- Must demonstrate the highest degree of ethics and integrity at all times