Associate Principal Scientist, Chemistry

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 methods and 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-functio