Senior Scientist, Engineering- Cell Banking Full-time NEW

Upstream Process Scientist

Our Scientists and Engineers support internal development and internal/external manufacturing operations to remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Scientists have opportunities across many areas including Biological, Chemical, Automation, Safety, Technical Services, Process Development, Analytical, Regulatory, and Quality.

As part of Our Company's Manufacturing Division, within the Biologics Drug Substance Commercialization (BDSC) organization, the upstream process science and technology department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. The group supports various cell bank and upstream drug substance process commercialization activities and second generation process development including cell banks, process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.

Under the general scientific and administrative direction of Director, and working in conjunction with internal and external partners, this person will support mid-late stage and commercial cell bank-related projects for large molecule programs. The person will be responsible for commercialization activities on late-stage pipeline and/or post-market commercial manufacturing working cell banks for biologics and/or vaccines. Activities include cell bank process assessments and transfers, manufacturing investigations and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.

Technical scope:

• Direct projects focusing on cell bank process risk assessments, documentation, process characterization, technology transfer and qualification of new cell banks with line-of-sight for licensure and commercialization.
• Responsible for planning and executing work to support commercialization of working cell banks, identification and implementation of process changes for replenishment lots, control strategies, manufacturing operations, investigation evaluations, and regulatory filings.
• Design, plan, and execute laboratory experiments to generate high quality data. Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports.
• Collaborate with research and commercial teams to deliver process documentation packages, review batch records, support technology transfer activities, and provide investigation support for cell bank manufacturing, both within our Company network and at contract manufacturing organizations (CMOs).
• Author required regulatory and technical documentation associated with cell bank process transfer, long term storage stability, qualification and licensure. Ensure that process/product are developed and documented according to standard company practices. Support regulatory queries and inspections as required.
• Provide technical leadership in the assessment of program-specific cell bank processes, interpretations of cell bank performance, as well as qualification approaches across programs. Implement and sustain technical standardization of best practices across the network.
• Lead assignment execution against accelerated timelines, in a right-first-time manner, with a “safety first, compliance always” mindset.

Minimum Required Education and Experience:

• Bachelor's Degree in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or a related field with five (5) years of cell culture experience in pharmaceutical industry; OR
• Master's degree in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or a related field with three (3) years of cell culture experience in pharmaceutical industry; OR
• Ph.D. in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or a related field with no industry experience.

Required Expertise and Skills:

• Fundamental understanding of cell line development, cell culture growth metabolism, cell death, and media adaptation.
• Hands-on experience and expertise in mammalian and/or microbial, adherent and/or suspension cell culture, including cell enumeration and expansion, virus infection, cryopreservation, cell bank preparation, and laboratory scale process operations in cell culture stacks, shake flasks
• Expertise in upstream lab scale experimental execution, Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions.
• Outstanding communication and people skills. Ability to foster a collaborative work environment, focused on common goals and working across boundaries.
• Acute problem-solving skills, project management, and keen ability to navigate work in an ambiguous environment.

Preferred Expertise and Skills:

• Large molecule process development, including laboratory and/or GMP manufacturing of upstream processes.
• Working understanding of US/EU regulatory requirements and analytical methods required to ensure viral safety and characterization of cell banks, and working knowledge of cGMP principles and regulations.
• Experience authoring technical documentation to support regulatory submissions.
• Hands-on expertise with mammalian cell culture bench scale and ability to oversee teams through these requirements as lab lead.
• Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, manufacturing batch record reviews and/or operations.
• Expertise with Quality by Design (QbD) and Lean Six Sigma principles.
• Expertise supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).

Required Skills:

Biologics, Biology, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Design of Experiments (DOE), Good Manufacturing Practices (GMP), Mammalian Cell Culture, Process Development (PD), Process Scale Up, Regulatory Submissions, Technology Transfer, Upstream Processing

Preferred Skills:

Salary range for this role is $117,000.00 – $184,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.