Job Description

The Global Vaccines and Biologics Commercialization (GVBC) team within our Manufacturing Division focuses on late-stage process development, technology transfer, and in-line support for large molecule products, including vaccines and biologics. As an Associate Principal Scientist in GVBC, you will play a key role in driving rapid biologics and vaccine characterization and process understanding. This laboratory-based position involves working with a diverse, expert team to implement process analytical technologies (PAT) such as LC-MS, spectroscopy, and chemometrics for both drug substance and drug product processes across the product lifecycle.

Candidates should have strong experience in spectroscopy (Raman, FTIR, NIR), multivariate modeling, and process control in biopharmaceutical manufacturing. The role includes collaborating with cross-functional teams to develop and optimize real-time process technologies, as well as creating regulatory strategies for the global acceptance of innovative control systems. Your work will help ensure the efficient, compliant commercialization of new products while supporting continuous improvement in manufacturing capabilities to meet our company's World Class Supply objectives.

Job role expectations:

• Partner with scientists in upstream cell culture/fermentation, purification, and drug product operations areas to identify opportunities and optimize the use of process analytical technology methods to support process and product development in the commercialization lifecycle phase.
• Develop and validate in-line, on-line or at-line PAT methods to monitor and control process parameters or product quality attributes to support process understanding, product development studies, and comparability assessments.
• Apply chemometrics and multivariate data analysis techniques for PAT calibration and spectral data interpretation in alignment with process data.
• Lead the systematic assessment and deployment of PAT tools/testing and enable enhanced process control strategies.
• Lead PAT scale-up and technology transfer to large scale manufacturing.
• Develop standard process analytics platforms encompassing all available tools to enable deep process understanding. These include, but are not limited to, biophysical/separations assays, in-line/on-line spectroscopic based methods (FTIR, Raman, NIR, etc.) and support other tools such as FBRM, on-line HPLC, in-line particle characterization, on-line MS.
• Develop integrated control strategies based on these analytical platforms that will enable highly capable manufacturing processes across a range of modalities (live virus and conjugate vaccines, mAb's, antibody-drug conjugates, and fusion proteins).
• Support scientific documentation, validation of PAT methodsand contribute to regulatory filling sections regarding PAT methods.
• Interface with global regulatory agencies to ensure successful regulatory filings regarding PAT methods for process control and/or release.
• Lead life cycle management strategy execution for commercial products.

Minimum Education Requirement and Experience:

• B.S. in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with eight (8) years of relevant industry experience; OR
• M.S. in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with six (6) years of relevant industry experience; OR
• Ph.D. in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with three (3) years of experience and a record of relevant publication

Required Experience and Skills:

• A record of relevant publications
• Demonstrated capability in development and validation of Process Analytical Technologies
• Technical proficiency in operation and troubleshooting of Spectroscopic instrumentation including Vibrational Spectroscopy (Raman, FTIR, NIR, etc.),
• Spectra interpretation, and analysis
• Data-driven qualitative and quantitative chemometric model building approaches

Preferred Experience and Skills:

• Fast learner, self-motivated to drive innovation with a problem solving mindset;
• Ideal to have bio-manufacturing process control experience with large molecule, but will consider small molecule
• Expertise with innovative process analytical technologies for vaccine and biologics
• Excellent communication skills. Must be able to communicate technical information both verbally and written in a concise manner;
• Must be able to work effectively in a cross-functional team environment;
• Hands-on experience using multivariate software platforms such MATLAB, SIMCA, Unscrambler for data analysis.
• Experience with PAT Manufacturing systems automation (SIPAT, Modbus, OPC, PLC)

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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:R321167