Job: GMP Technical Operations Lead Process Engineer (101153), Duke Human Vaccine Institute, Durham, NC
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 lead all aspects of multiple cGMP campaigns and mentor junior staff.
• Provides manufacturing leadership 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.
• As the lead of manufacturing campaign execution, collaborates closely with product specific development teams to execute tech transfer from the process development scale to the manufacturing scale and works diligently with development functions to complete required scale-up activities for transfer into the cGMP facilities whilst understanding how the production process changes driven by scale up impact product quality.
• Maintains all materials required for cGMP production of project specific manufacturing campaigns, including working with vendors to: design process and product specific single use components; meet DHVI shipping/delivery/documentation needs; and performs investigations which include creation of detailed reports, presentation of trends/risks/and recommendations to wider cGMP team / Quality, and negotiates pricing. Maintains cGMP equipment and facilities for technically complex equipment and systems, including working with vendors to meet DHVI calibration/repair/documentation needs, performs investigations, and negotiates pricing. Manages quotation and justification submission documents 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 complex and challenging equipment items, such as dual-use reactors, single use chromatography systems, and fill/finish isolators. 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, including equipment characterization activities such as reactor kLa studies, fill/finish VHP studies, and critical process media challenge studies; 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.
Required Qualifications at this Level
• Education/Training: Bachelor's degree in a science, engineering, or related field. A Master's degree is preferred.
• Experience: 4 years relevant experience in the biopharmaceutical industry or equivalent.
• Preferred experience that include the following:
o Experience with cGMP Cell Banks and/or Drug Substance and/or Drug Product manufacturing (clinical manufacturing and/or licensed product manufacturing)
o Solid understanding of cGMP regulations for Vaccines and/or Biologics
o GDP experience in an agency-regulated manufacturing environment
o Experience with visual management use and/or development
o Experience authoring and/or approving controlled documents
• Direct experience interfacing with cGMP regulatory agencies
• cGMP Facility and/or equipment start-up experience
• Direct experience working with third-party vendors
• cGMP Vaccine and/or Biologics manufacturing experience (clinical manufacturing and/or licensed product manufacturing)
• 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