Job Description

The Global Vaccines and Biologics Commercialization (GVBC) team within our Company Manufacturing Division is dedicated to the late-stage process development, technology transfer, and ongoing support of large molecule products, including vaccines and biologic therapeutics. Our mission is to ensure a compliant and cost-effective supply of our top-tier inventions to patients through technical excellence. We support manufacturing sites by commercializing our pipeline and offering technical assistance in the production, testing, and release of our products.

As a member of the Process Attribute Sciences (PAS) team, you will join a dynamic and inclusive group of expert scientists and engineers. Under the general scientific and administrative direction of the Director in ComPAS, this individual will lead and oversee the advancement of Process Analytical Technology (PAT) in GVBC. We are seeking a highly skilled and innovative Principal Scientist to be responsible for development, optimization, and implementation of new in-line, on-line and at-line analytical technology to support biologics and vaccine process understanding in our Company Manufacturing Division. The ideal candidate will possess experience in people management and cross-functional collaboration. The individual will manage a team of PAS scientists and will ensure that GVBC delivers an outstanding level of rigor in our scientific work and commercialization support activities.

You will have the opportunity to collaborate with GVBC teams, Large Molecule Technical Operations (LMTO), and Research Division partners to implement PAT platforms that enhance manufacturing capabilities in our commercialization and in-line product manufacturing facilities. You will also be responsible for developing regulatory strategies to secure global acceptance of innovative control strategies that will be filed with our portfolio of large molecule products. Your contributions will include the development and implementation of advanced real-time technologies to support new product development and process control applications in manufacturing, helping our Company achieve its World Class Supply objectives.

Job role expectations:

• Leadership in PAT deployment: Lead the systematic assessment and deployment of in-line, on-line, and at-line PAT methods across upstream cell culture, fermentation, purification, and drug product operations for our large molecule pipeline and in-line programs.
• Lead a team of 3-5 scientists/engineers in execution of PAT projects across the large molecule commercialization and in-line product portfolio.
• Design and develop standard analytical platforms aimed at enabling PAT, including but not limited to in-line/on-line monitoring and rapid shop floor analytics
• Lead the effort to develop innovative PAT solutions for new product modalities including antibody drug conjugates (ADC's), peptides, and multi-specific antibody therapeutics
• Manage PAT scale-up and technology transfer to large scale manufacturing.
• Create and implement integrated control strategies based on PAT platforms to facilitate both batch and continuous manufacturing
• Collaborate with new facility capital project teams to design and establish integrated PAT infrastructure, ensuring alignment with the strategic vision of next-generation manufacturing platforms.
• Drive division wide PAT initiatives that will enable our Company's vaccine/biologics manufacturing strategic goals.
• Mentor and support the professional development of direct reports
• Foster a culture of innovation and technical excellence within the team.

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) degree in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with fourteen (14) years of experience in the biopharmaceutical industry, specifically in process development, analytical development, and manufacturing. OR
• Master of Science (M.S.) degree in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with twelve (12) years of experience in the biopharmaceutical industry, specifically in process development, analytical development, and manufacturing. OR
• Ph. D in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with eight (8) years of experience in the biopharmaceutical industry, specifically in process development, analytical development, and manufacturing.

Required Experience and Skills:

• Process Analytical Technology (PAT) experience
• A record of relevant publications

Preferred Experience and Skills:

• Regulatory filing experience regarding PAT
• Strong experience in managing cross-functional teams and projects, with excellent interpersonal and people management skills.
• Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Requisition ID:R338232