Senior Scientist - Process Analytical Technology; On-site

Position: Senior Scientist - Process Analytical Technology (On-site)
** Job Description*
* ** Senior Scientist - Process Analytical Technologies (PAT)*
* We are seeking a Senior Scientist to join the Process Analytical Technologies (PAT) team within Analytical Enabling Capabilities at our company. As a member of the PAT team, you will integrate with a motivated and inclusive team of expert scientists passionate about PAT tools application from process development to routine manufacturing.

This role offers an exciting opportunity to contribute strong mechanistic organic chemistry expertise to support small molecule active pharmaceutical ingredient (API) process development, with a particular emphasis on reaction mechanism elucidation, reaction monitoring, and impurity understanding.

** Responsibilities*
* + Provide technical leadership for systematic assessment and deployment of in-line, on-line, and at-line PAT methods for API and biologics drug substance development programs.

+ Partner closely with process chemistry teams to define mechanistic questions, design hypothesis-driven studies, and translate mechanistic insights into actionable process development recommendations.

+ Apply PAT to support reaction monitoring, kinetic assessment, intermediate identification, impurity profiling, and structure confirmation during API process development.

+ Design and develop standardized analytical platforms to enable PAT implementation, including real-time monitoring and rapid shop-floor analytics.

+ Develop, validate, and implement PAT methods (in-line, on-line, at-line) to monitor and control process parameters and product quality attributes.

+ Lead scale-up activities and technology transfer of PAT applications to commercial manufacturing.

+ Create integrated control strategies that leverage PAT platforms to enable robust, highly capable manufacturing processes.

+ Prepare and maintain scientific documentation and validation packages for PAT methods; contribute content for regulatory submissions.

+ Interact with global regulatory agencies as needed to support acceptance of PAT-based process control and release strategies.

** Qualifications*
* _Required_

+ B.S./M.S in chemistry, biochemistry, biotechnology, bioengineering, chemical engineering, or a related discipline with a minimum of 3 years of relevant industry experience; or Ph.D. and 0+ years.

+ Strong technical background in elucidation of organic reaction mechanisms as applied to API process development.

+ Strong technical background in optical spectroscopy (Raman, FTIR, NIR), NMR, chromatography, and chemometrics.

_Preferred_

+ Proven track record of scientific contributions (peer-reviewed publications or equivalent technical outputs).

+ Experience supporting pharmaceutical or fine chemical process development, including mechanistic understanding, process optimization, scale-up troubleshooting, control strategy development, and robustness studies.

+ Strong collaborative and interpersonal skills; ability to work across functions and with external partners.

EligibleforERP

ARD

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* Required Skills:

*
* Analytical Method Development, Assay Development, Chromatographic Techniques, GMP Environments, Nuclear Magnetic Resonance (NMR) Analysis, Process Analytical Technology (PAT), Technical Writing, Ultra Performance Liquid Chromatography (UPLC)

** Preferred

Skills:

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* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  ()  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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