Job: GMP, Associate Scientist/Eng. II - Bioprocess, Duke Human Vaccine Institute, Durham, NC
Designs experiments, executes and documents GMP activities in compliance with regulatory requirements.
Collaborates closely with development teams to provide support for development activities and works diligently with development functions to understand how the production process changes impact product quality.
Compiles data and performs analysis and 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 GMP program.
Writes and reviews technical reports; writes protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.
Manages all materials required for CGMP production, including working with vendors to meet DHVI shipping/delivery/documentation needs, performs investigations which include creation of detailed reports, presentation of trends/risks/and recommendations to wider GMP team / Quality, and negotiates pricing. Maintains CGMP equipment and facilities, 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 GMP facility materials / components / equipment / and services.
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 audits to ensure compliance. Trains the GMP team on proper documentation practices and acceptable corrective actions for a GMP compliant organization.
Provides hands-on support 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 / documentation events.
Provides assistance, including commissioning / qualification / protocol documentation ownership and support, for current and new facility for complex and challenging equipment items, such as dual-use reactors and single use chromatography systems. 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.
Creates and deploys training/SOP/change control documentation as needed.
You will only be considered for the position after you have applied to requisition 4391 on the DHVI careers page.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.