Senior Scientist, BioProcess Engineering - West Point, United States - Merck

Description

Job Description

As part of the Manufacturing Division, the Biologics Drug Substance Commercialization (BDSC) department provides the Drug Substance technical process leadership and laboratory capabilities in support of late-stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). Within BDSC Biologics Process Engineering (BPE), we partner across areas of our Manufacturing Division and cross-divisionally with our Research & Development Division with the ultimate goal of delivering innovative products to patients.

For pipeline programs, BDSC Biologics Process Engineering leads various commercialization activities, including technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, the scope includes support of site-to-site process transfers, process enhancements, next generation process (i.e., post approval) development and process characterization support, process validation, and regulatory submission authoring. Through process engineering, we ensure that our company's biologics processes can be scaled up or scaled out into the manufacturing facilities with our respective partners.

Under the general scientific and administrative direction of a Director, Biologics Process Engineering and working in conjunction with internal and external partners, this individual will support late stage and commercial biologics program activities within BDSC. This individual will demonstrate scientific, experimental and technology transfer skills leading either upstream or downstream work while collaborating with partners to drive overall drug substance technology transfer, analytical and process modeling activities.

Responsibilities:

• Serves as a sub-team lead for and participates on cross-functional teams in support of technology transfer, process validation/PPQ, facility fit, risk assessments, manufacturing campaigns, process and plant modeling, regulatory filings (IND/BLA/PAS) and post approval life cycle management.
• Provides technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA))
• Provides technical leadership for technical investigations and process changes that seek to drive improvements to yield and/or robustness.
• Partners with laboratory on the design of experiments, data analysis and interpretation of bench/pilot scale studies to support technology transfer and process characterization.
• Partners with multiple functions, including the manufacturing site, to establish the commercial process description and integrated control strategy.
• Primary focus will be either drug substance upstream or downstream processing, depending on experience, but position requires a working knowledge of the various aspects of product manufacture and functional area interdependencies, including other areas of drug substance processing, analytical, and site readiness.
• Actively interacts with internal and external counterparts. May represent functional area on cross-functional and cross-divisional teams and leads technical teams through matrix structures.
• Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to standard our Company practices.

Education Minimum Requirement:

• BS, MS or PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 6+ years for BS, 4+ years for MS, 0+ year(s) for PhD of relevant experience.

Required Experience and Skills:

• Experience with the manufacturing of drug substance biological molecules. Demonstrated understanding of the fundamentals and/or modeling of unit operations.
• Experience with late-stage process development, process characterization, technology transfer, facility fit assessments, commercial control strategy, process validation/PPQ, manufacturing site readiness and regulatory submissions (IND, BLA, PAS).
• Ability to effectively articulate understanding of process engineering to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
• Excellent oral and written communication skills.

Preferred Experience and Skills:

• Technical operations experience in the manufacture of biological molecules at the pilot- and/or commercial-scale.
• Direct experience working with internal and external contract manufacturing organizations.
• Prior experience with PAI, regulatory inspections and working knowledge of cGMPs.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
• Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.
• Working understanding of analytical methods to characterize biologics.
• Application of process and/or economic modeling related to biologics drug substance manufacturing.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R286701