Associate Principal Scientist, Upstream Process Development

Merck; New Jersey; On-site; USD 120,000 - 180,000; Full time

Job summary

Merck is seeking an Associate Principal Scientist in Upstream Process Development to lead mammalian cell culture process development for clinical and commercial programs. You will design, optimize, and transfer scalable processes to manufacturing, partnering with Discovery, Downstream, and Manufacturing teams.

A strong track record in CHO biology, DoE, and cross-functional collaboration is essential. You will mentor junior staff, publish results, and contribute to regulatory submissions while

Qualifications

• Ph.D. with 4+ years in chemical engineering, Bioengineering, Biological Engineering, or related field.
• Hands-on mammalian cell culture and fed-batch processes for recombinant protein production.
• Strong knowledge of CHO cell biology, metabolism, and large-scale production principles.
• Experience with DoE and multivariate data analysis; proficient in SIMCA and JMP.
• Proven upstream process development accomplishments and publications/presentations.

Responsibilities

• Leads upstream process development for first-in-human and commercial processes; develops high-yield, robust, scalable cell culture processes.
• Conducts process development, characterization, and regulatory filing activities to support PPQ and BLA.
• Collaborates across Discovery, Cell Line, Downstream, Analytical Sciences, and Manufacturing for integrated processes.
• Advances platform processes through improvement initiatives to boost efficiency and cut costs.
• Engages with academia, industry, and vendors to drive new process technologies; publishes and patents as appropriate.

Skills

Mammalian cell culture

CHO biology

Design of Experiment

Multivariate data analysis

Scientific publications

Collaboration

Communication skills

Problem solving

Bioreactors

Bioreactor simulation

Education

Ph.D. with 4+ years' experience

Master's with 8+ years' experience

Tools

SIMCA

JMP

Job description

The Biologics Process Research & Development organization within our Research & Development Division is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and energetic individual to join our team as an Associate Principal Scientist. In this role, a successful candidate will work closely with a highly motivated team of Scientists and Engineers in the Upstream Process Development area and contribute to CMC development of our company's pipeline, playing an active role in the design, development, and optimization of cell culture processes and the transfer of processes to clinical and commercial manufacturing sites. They must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership in Upstream process development, and superior written and oral communications abilities. Evidence of strong cross-functional collaboration, significant external presence with scientific excellence, and interest and abilities for mentoring junior staff are also expected.

Responsibilities include, but are not limited to:

• Participates in and/or leads upstream process development of first-in-human and commercial processes by efficiently developing high yield, robust, and scalable cell culture processes.
• Responsible for process development, process characterization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
• Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies.
• Advancing the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.
• Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.
• Keep current with the external literature environment; actively present and publish externally and pursue patenting strategies.

Minimum Education Requirements:

• Ph.D. with 4+ years' experience or Master's with 8+ years' experience in chemical engineering, Bioengineering, Biological Engineering, or a related field

Required Experience and Skills:

• Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins.
• Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems.
• Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.).
• Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and bioreactor scale-up principles from laboratory to large scale.
• Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
• Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
• Plan, execute, analyze, and communicate complex and critical data in a highly organized manner.
• Excellent verbal, written communication, and interpersonal skills.
• Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• Productivity and efficiency working in the laboratory.
• Ability to deliver complex objective under aggressive timelines.
• Proficiency in Bioreactor simulation and modeling.

Preferred Experience and Skills:

• Experience with cell culture media development.
• Experience with high throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.
• Background in data science approaches related to cell culture and predictive modeling, e.g. metabolic flux (MFA) analysis, omics, machine learning; computational fluid dynamics, and experience integrating PAT efforts.
• Experience with late-stage commercial process development, technology transfer, scale-down model qu