Senior Scientist, Engineering

** Job Description*
* The Pharmaceutical Commercialization Technology (PCT) department is seeking a Senior Engineer based in Rahway, NJ. The group sits within the Manufacturing Division and is responsible for pharmaceutical process and technology development for small molecule solid dosage drug products, bringing new and novel medicines to patients worldwide. PCT leads process development as products enter Phase IIb through regulatory filings, process validation, and for several years beyond commercial launch.

Products are commercialized at a network of internal manufacturing sites, located in Ireland and Singapore, as well as contract manufacturing organizations around the world. Coupled with development centers in Rahway, NJ and West Point, PA, these sites are the foundation of our extensive small molecule solid dosage development and commercialization capabilities.

Success in this role requires strong communication and collaboration within teams, a growth mindset and eagerness for continuous learning, a passion for science and solving technical problems, and hands-on development and manufacturing from pilot to commercial scale. Partners include research and development, analytical, regulatory, quality, packaging, and operations at our commercialization and commercial supply sites. We recognize that the diversity in our team is our strength and are dedicated to creating an inclusive environment for all employees.

Key Responsibilities:

+ Plan, conduct, and interpret pharmaceutical process development studies, such as scale up, technology transfer, design space development, clinical and stability batch manufacture, and process validation.

+ Participate in or lead drug product working groups and technology development teams and represent the department in cross-functional interactions.

+ Apply problem-solving skills and aspects of Quality by Design, including risk-based approaches to development, design of experiments, and process modeling.

+ Author technical documents, such as experimental protocols, reports, and regulatory filings.

+ Demonstrate oral and written communication skills and effective collaboration and leadership within teams, including commercial sites and/or third-party vendors.

+ Evaluate new and innovative technologies and equipment, perform physical testing and data analysis, and comply with applicable safety and current good manufacturing practices.

+ Contribute to publications and presentations within the scientific community as appropriate.

+ Advance innovation and digital and data analytics capabilities.

** Education Minimum Requirement:*
* Bachelor's degree and 6 years related experience, master's degree and 4 years related experience, or PhD (no additional experience required) in Chemical/Biochemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related discipline.

** Required

Experience and Skills:

*
* + Proven ability to work both independently and as part of a team and execute against commitments.

+ Demonstrated capability to design and execute an experimental program with mechanistic understanding, process robustness, productivity, and cost in mind, and integrate efforts with specialists from other technical disciplines.

+

Experience with process scale-up and/or technology transfer, moving between laboratory, pilot, and commercial scale.

+ Hands-on experience in a laboratory, pilot plant, or manufacturing facility.

** Preferred

Experience and Skills:

*
* + Familiarity with concepts and application of cGMP during pharmaceutical development and production.

+ Experience authoring the Chemistry and Manufacturing Controls (CMC) sections of New Drug Applications/Worldwide Marketing Applications (NDAs/WMAs).

+

Experience with one or more of the following: (1) Analytical tools for analyzing big data and process performance, (2) Development, application, or validation of process models, (3) Development or application of statistical process control techniques, and/or (4) Knowledge and use of statistical techniques as applied to product sampling and release.

+ Experience in supporting partners in supply, including either support of process validation preparation and execution or products post-validation.

+ Experience interacting with commercial sites and/or third-party vendors during development and/or clinical or supply manufacturing.

+ Experience in pharmaceutical drug substance or drug product development or similar.

*
* Required Skills:

*
* cGMP Regulations, Chemical Engineering, Chemistry,…