- Required: B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology
- Preferred: Master's degree; or Ph.D. with relevant academic experience.
- BS + 4 years of experience; MS + 2 Years of experience or PhD candidates.
- Large molecule process development, or relevant, experience including scaling (up and down) and tech transfer of upstream large molecule drug substance processes (aseptic-flasks, bioreactors, single use systems).
- Subject Matter Expertise with Upstream lab or pilot-scale fermenters/bioreactors/cell culture running microbial and/or mammalian cell based large molecule processing.
- 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 upstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling.
- 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 Merck.
- 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.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.