The Vaccine Process Development and Commercialization group within our client's manufacturing division focuses on late stage process development, technology transfer, and support of established vaccine products. Our client is seeking an energetic, people-oriented professional with strong scientific and technical skills to execute the tech transfer activities of multiple vaccine programs with a focus on upstream manufacturing process ( Drug Substance ). In this role, you will be responsible for:
- Planning, executing, documenting and reporting on tech transfer activities according to the client's tech transfer policies and SOPs.
- Designing and executing or overseeing the execution of experimental plans designed to understand the process and its robustness ( Identification and characterization of Critical Process Parameters and of Critical Material Attributes ).
- Required: B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology
- BS + 3 years of experience; MS + 1 Year of experience or PhD candidates.
- Expertise in tech transfer of upstream vaccine or biotech processes from R&D to commercial scale facility or from one commercial scale facility to another.
- Subject Matter Expertise with Upstream lab or pilot-scale fermenters/bioreactors/cell culture running microbial and/or mammalian cell based large molecule processing.
- Large molecule process development, or relevant, experience including scaling (up and down) of upstream large molecule drug substance processes (aseptic-flasks, bioreactors, single use systems).
- Expertise in lab scale experimental execution and experience with Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions.
- Experience authoring technical documentation to support regulatory submissions.
- Outstanding communication and people skills.
- Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
- Experience with project strategic planning.
- cGMP experience.
- Knowledgeable in Drug Substance, end-to-end process development.
- Experience with Quality by Design (QbD) and Lean Six Sigma principles.
- Strong cross-functional background, enabling teams to reach peak performance.
- Ability to provide scientific mentorship and guidance to technical coworkers and colleagues within and outside of the client.
- Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA) .
- Experience with on-the-floor GMP manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations