Overview
We are seeking an experienced and innovative Associate Principal Scientist to join the Process Analytical Technologies (PAT) team within Analytical Enabling Capabilities. In this role, you will collaborate with a cross-functional, highly engaged team to advance the development pipeline and support commercial manufacturing. The successful candidate will lead the development, validation, and implementation of in-line, on-line, and at-line PAT solutions for both small- and large-molecule modalities. Join our company and contribute to our mission of delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals.
Responsibilities
- Provide technical leadership for systematic assessment and deployment of in-line, on-line, and at-line PAT methods across small- and large-molecule programs.
- 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.
- Partner with capital project and facility teams to design and establish integrated PAT infrastructure aligned with the Launch Preparedness strategy.
- Create integrated control strategies that leverage PAT platforms to enable robust, highly capable manufacturing processes across modalities (e.g., small molecule drug product, biologics, and vaccines).
- 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
- B.S. in chemistry, biochemistry, biotechnology, bioengineering, chemical engineering, or a related discipline with a minimum of 12 years of relevant industry experience; or M.S. with at least 8 years; or Ph.D. with at least 4 years.
- Demonstrated experience in PAT.
- Strong technical background in spectroscopy (Raman, FTIR, NIR), chromatography, and chemometric/modeling approaches.
- Proven track record of scientific contributions (peer-reviewed publications or equivalent technical outputs).
Preferred
- Experience preparing PAT content for regulatory filings and interacting with regulatory agencies.
- Experience with PAT implementation in commercial manufacturing and technology transfer.
- Strong collaborative and interpersonal skills; ability to work across functions and with external partners.
- Project leadership and the ability to manage multiple priorities in a fast-paced environment.
Required Skills
- Adaptability, Analytical Method Development, Assay Development, Biodesign, Biological Assay Development, Cell-Based Assays, Chemical Engineering, Chemometrics, Chromatographic Techniques, Chromatography, Cross-Functional Collaboration, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Process Analytical Technology (PAT), Project Leadership, Real Time Monitoring
Additional Information
- US And Puerto Rico Residents Only
- Our company is committed to inclusion and provides accommodations during the application or hiring process if needed.
- As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on protected characteristics.
- Salary range: $142,400.00 - $224,100.00. Eligible for annual bonus and long-term incentive, if applicable.
- Hybrid work model in the U.S. with three on-site days per week (details in posting).
- Travel requirements: 10%
Requisition ID: R
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