Associate Principal Scientist, 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 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 support, characterization, technology transfer, post approval process development and validation studies for Merck’s commercial biologics products as well as pipeline programs. The individual will demonstrate scientific, experimental and technology transfer skills focused on cell culture processes. This role is primarily focused on late stage process development/commercialization including raw material understanding and management.
We seek an energetic, people-oriented leader with strong interpersonal, communication, collaboration, people, scientific and technical skills to lead the manufacturing sciences development/commercialization activities, post approval support, post commercial process enhancements activities for multiple inline/pipeline therapeutic protein programs.
- Provide technical/team support and leadership (matrix, project) in manufacturing sciences for late stage cell culture process development, scale-down model development/execution/implementation, process characterization, commercial technology transfer, and qualification studies associated with the development and implementation of bulk processes, systems and facilities related to biologics products.
- Support definition and development of process control strategy including identification of critical process parameters and critical material attributes for upstream process and raw materials (including media/feed components)
- Partnering with commercial manufacturing teams to provide post approval support and upstream subject matter expertise support to ongoing manufacturing activities.
- Supporting evaluation and development of innovative process technologies, continuous process improvements and post commercial process enhancements (including development of next generation processes post approval) to support in-line products
- Application of science and risk-based approaches to the characterization and qualification of raw materials (including complex media and nutrient feed components) for the biologics manufacturing.
- Deep SME for manufacturing investigations support (Product and process deviations and complex material-related)
- Collaborate with internal/external partners (Raw material suppliers, external manufacturers etc.)
- Development of effective data analytics methodologies for process and raw materials (e.g., statistical process control (SPC) and/or multivariate analyses (MVA).
- Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to process and raw materials
- 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 10 years of relevant experience; or Master's degree with 8 years of relevant experience; or Ph.D. with 4 years of relevant experience.
- Minimum of (3+) year industry experience in upstream mammalian process development and commercialization along with commercial tech transfer of cell culture processes.
- Technical expert on post approval support and post commercial process enhancements
- Deep technical knowledge and in-depth experience with upstream process development including expertise in harvest and primary recovery unit operations (centrifugation, depth filtration) and raw materials
- Ability to drive studies and experiments in the context of long-term commercialization plan.
- Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles.
- Solid experience in using statistical tools (JMP, Spotfire and SIMCA) for data mining, data analysis and modeling.
- Experience supporting/writing regulatory filings (IND, BLA), responding to regulatory questions and inspections with multiple agencies (FDA, EMA, JNDA,).
- Experience with project strategic planning.
- cGMP experience will be a solid plus
- Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
- Proven team leader with influence and outstanding communication (including presentation) and people skills
- Ability to work in a matrix environment, collaborating across multiple sites and functional areas; strong communication and collaboration skills are a must have.
- Upstream process development/commercialization and Raw Material technical management expertise with multiple programs and unit operations.
- Knowledgeable in Drug Substance, end to end process development.
- 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.
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