Associate Principal Scientist; Downstream Vaccines Process Development and Commercialization
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Vaccine Process Development and Commercialization (V-PDC) group within the Merck Manufacturing Division (MMD) focuses on late stage process development, technology transfer, and in-line support of vaccine products. We seek an energetic, people-oriented leader with strong scientific and technical skills to lead the development and commercialization activities supporting multiple vaccine programs. In this role, you will be responsible for:
- Leading process development activities to execute large molecule upstream processing including lab-scale process development, in-process assay support, and process scale-up/scale-down.
- Execution of lab scale experiments and authoring associated technical reports and documents.
- Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within the Merck network and at contract manufacturing organizations (CMOs).
- Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
- Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
Provide mentorship and technical direction to other members of the team which may include dotted-line reporting relationships.Qualifications
- B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 7 years of relevant experience; or Master's degree with 5 years of relevant experience; or Ph.D. with 3 years of relevant experience.
- 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.
- Experience with large molecule assay development and execution (HPLC, UPLC, MS).
- 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
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Process Engineering
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck