Senior Scientist, Upstream Biologics Process Development & 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.
As part of the Merck Manufacturing Division, and operating within Global Vaccines and Biologics Commercialization (GVBC), the Biologics Process Development and Commercialization (BPDC) department provides manufacturing sciences expertise, through technical process leadership and laboratory capabilities, in the commercialization and post-launch support of Merck’s biologics pipeline. Working closely with colleagues across the biologics network, including Merck Research Labs (MRL), Operations, and Global Technical Operations (GTO), our department supports upstream cell culture, downstream purification, analytical testing and characterization, and technology transfer of biological processes (therapeutic proteins) from Phase III through commercial launch and transfer to the commercial supply network.
For the in-line support of commercial biologics, including, but not limited to, KEYTRUDA and ZINPLAVA, we provide deep scientific support for investigations, post-launch process enhancements, technology transfers, and the development and characterization of next generation processes post-approval. For pipeline biologics, we support various commercialization activities, including scale-up/scale-down, process characterization and validation, technology transfer and authoring of regulatory submissions.
Under the general scientific and administrative direction of the Director of BPDC Upstream Process Development and Commercialization, and working in conjunction with internal and external partners, this individual will support late stage drug substance process development and characterization, technology transfer, and post-approval process development and validation studies for Merck’s commercial biologics products as well as pipeline programs. The individual will demonstrate strong scientific, experimental and technology transfer leadership and skills focused on cell culture processes.
- Provide technical support and leadership in manufacturing sciences for drug substance development, characterization and commercialization teams, including the design, execution, and interpretation of lab-scale, pilot-scale and manufacturing-scale elements of a technical program to ensure processes are suitable for Process Performance Qualification (PPQ), licensure, and commercial manufacturing
- Support definition and development of process control strategy
- Support the continuous improvement of commercial manufacturing processes
- Support new/innovative technologies and work to implement new platforms with cross-functional early and late stage development teams
- Manage technical programs, including establishing and delivering on project timelines and milestones
- Partnering with commercial manufacturing teams to provide upstream subject matter expertise to support ongoing manufacturing activities
- Provide global support for commercial products (e.g. technical support, trouble shooting, deviation resolution, change control)
- Author, review and edit technical documents to support regulatory filings including technical reports, risk assessments, and CTD sections
- B.S. in Chemical Engineering or Biochemical Engineering or related field with 6 years of relevant experience; or Master's degree with 4 years of relevant experience; or Ph.D. with 0+ years of relevant experience in the above mentioned field
- Upstream process development, characterization and manufacturing sciences experience, including scaling (up and down) along with technology transfer, of mammalian cell culture and/or microbial fermentation processes
- Commercialization experience in biologics, vaccines or other therapeutic proteins
- Deep technical knowledge and in-depth experience with upstream process development
- Ability to design and execute studies and experiments in the context of long-term commercialization plans
- Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles
- Experience in using software and statistical tools (JMP, Spotfire, SIMCA) for data mining, multivariate data analysis (MVDA), modeling and statistical process control (SPC)
- Experience with project strategic planning
- Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development
- Outstanding communication and people skills. Ability to work in a matrix environment, collaborating across multiple sites and functional areas
- Actively listens and participates in discussions and is appropriately assertive in expressing own ideas. Gives timely constructive feedback when appropriate
- Flexibility and agility in responding to changing needs across BPDC and Merck
- Delivers what is needed on-time and holds self and team accountable for commitments, decisions, actions and behaviors
- Upstream process development, characterization and manufacturing sciences expertise across multiple programs and platforms
- Expertise in harvest and primary recovery unit operations (centrifugation, depth filtration) is a plus
- Knowledgeable in Drug Substance, end to end process development. Strong cross functional background, enabling teams to reach peak performance
- Experience supporting/writing regulatory filings (IND, BLA) and inspections with multiple agencies (FDA, EMA, JNDA)
- cGMP experience
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, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck