Principal Scientist, Upstream Process Development

Merck; Rahway (NJ); On-site; USD 150,000 - 210,000; Full time

Job summary

Merck in Rahway, NJ seeks a Principal Scientist to lead cross-functional teams in developing CMC packages for biologics. You will direct upstream process development, scale-up, and tech transfer for cell culture assets advancing from early development to clinic and commercial supply.

The role requires a Ph.D. with 6+ years in industry, strong leadership, and a track record of publications and collaborations, plus experience with CHO fed-batch work, DOE, and CFD.

Qualifications

• Ph.D. with 6+ years of industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field.
• Proven record of upstream process development with publications and presentations.
• Experience in CHO fed-batch cell culture and understanding of downstream analytics.
• Hands-on experience with bioreactors at bench-to-pilot scale and tech transfer activities.
• Knowledge of DOE statistics and computational fluid dynamics.
• Ability to lead planning, execution, analysis and documentation of cell culture process development.
• Ability to work in a matrixed team and collaborate with vendors and partners.

Responsibilities

• Leading biologic upstream process development for first-in-human and commercial processes.
• Providing technical direction for process development, characterization, commercialization, and regulatory filings.
• Advancing upstream platform process strategy and championing continuous improvement initiatives.
• Initiating collaborations to assess new technologies and industry strategies.
• Collaborating with academia, industry partners, and vendors to drive development and innovation.
• Mentoring and educating junior scientists.

Skills

Upstream process development

Cell culture

Cross-functional leadership

DOE statistics

Process scale-up

Tech transfer

Education

Ph.D. in Chemical/Bioengineering/Biochemistry

Job description

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.

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 experienced individual to join our team as a Principal Scientist. In this role, the successful candidate will lead cross-functional teams to develop CMC packages for our pipeline assets. The successful candidate will also collaborate with fellow Bioprocess Development colleagues to develop and refine technical strategy related to next generation processing for assets in early- and late-stage clinical development. Applicants must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems are distinguishing. Evidence of strong cross-functional collaboration, experience successfully mentoring junior scientist, leading projects, and strong external presence through scientific excellence are expected.

Job Responsibilities

The successful candidate will contribute to CMC development of our Company's pipeline, playing an active role in development of cell culture processes and transfer to clinical and commercial manufacturing sites. They will also develop strategies for process and pipeline-facing innovation. Responsibilities include:

• Leading biologic upstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes.
• Providing technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs an BLAs for our company pipeline.
• Advancing upstream platform process technical strategy and championing creative process improvement initiatives
• Initiating new collaborations to assess new technologies and industry strategies with relevance to our Company.
• Collaborating with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies with broad impact to projects or platform.
• Keeping current with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies.
• Mentoring and educating junior scientists
  
  

Minimum Education Required

Ph.D. with 6+ years of industry experience or Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field

Required Experience And Skills

• Proven record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
• Experience in CHO fed-batch cell culture and a working understanding of downstream & analytics.
• Understanding and hands-on experience on cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities.
• Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics and computational fluid dynamics.
• Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
• Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors.
• Knowledge of biologics CMC development cycle.
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• Demonstrated ability to develop staff to maximize utilization of talent and actively guides career development; builds strong and collaborative teams.
  
  

Preferred Experience And Skills

• Experience with state-of-the-art cell culture processes including intensified inoculum and perfusion process development.
• Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
• Expertise in media development, media/solution chemistry.
• Background in data science approaches related to cell culture and predictive modeling e.g., metabolic flux analysis (MFA), omics, machine learning; experience integrating PAT efforts) and computational fluid dynamics (CFD).
• Experience leading cross functional, program development teams.
  
  

Required Skills

Adaptability, Cell Culture Process Development, Cell Line Development, Combination Products, Data Analysis, Finite Element Analysis (FEA), Innovative Thinking, Leadership Mentoring, Pharmaceutical Process Development, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Strategic Thinking, Technology Transfer

Preferred Skills