Job Description
- The Senior Process Engineer supports drug substance technology transfers across the client’s biologics pipeline, spanning early phase, late phase, and commercialization within CMC.
- As a technical subject matter expert, this role partners with Process Development and Clinical Supply (PDCS), the internal non-GMP pilot network, Operations, Quality (QA), Regulatory (RA), and internal/external manufacturing sites to plan and execute transfer activities, ensure GMP-compliant manufacture, and drive process readiness.
- The Senior Process Engineer develops standards, guidance, and tools to improve the effectiveness of technology transfers; serves as the technical SME and manages activities associated with GMP manufacturing and process validation; supports clinical and commercial regulatory submissions (e.g., IND/IMPD, BLA/MAA); and contributes to the development of robust raw material control strategies (including alternate material evaluations, specification justification, and risk assessments).
- Depending on business needs, the role may provide support across any or all these areas.
- Support continuous improvement of efficiency of technology transfer processes through development of standard operating procedures, job aids, & supplemental reference/training materials and with alignment to ongoing digitalization initiatives.
- Work in partnership with Biologics Drug Substance leadership and SMEs to lead the development and implementation of robust raw material control strategy, inclusive of raw material assessments and justification of specifications.
- Serve as technical SME for routine activities for biologics tech transfer & GMP manufacture and validation including but not limited to creation/review of technical protocols or reports, manufacturing records, & quality records, sample plan coordination, and monitor & trend manufacturing batch performance.
- Support compilation of data for regulatory source documents & perform technical review of IND/IMPD, BLA/MAA for regulatory submissions.
- A degree in related Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Biochemical, Mechanical) field. A PhD, a MS with at least 6 years of relevant experience, or a BS with at least 8 years of relevant experience.
- Experience and in-depth technical, and operational knowledge of multiple drug substance unit operations including cell culture, centrifugation, filtration, UF/DF, and chromatography.
- Comprehensive understanding clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure manufacturing operations are GMP compliant.
- This role is primarily office based, with requirement for routine on-site presence at the designated office. Ability to travel domestically up to two weeks (total on average ~25%) at a time for manufacturing site support.
- During travel for manufacturing support, this role requires physical capabilities to gown and de-gown PPE in GMP cleanroom environment and be present during manufacturing operations in a technical support role. Physical elements include standing, climbing stairs, ladders, visual capability to read manufacturing control screens, use a computer, engage in communications via phone, video, and electronic messaging.
- Ability to drive for results independently and adapt to rapidly changing priorities.
- Effective problem solving and technical decision-making skills in a manufacturing environment.
- Strong oral and written communication skills and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners.
- Excellent collaboration skills, with ability to participate in global cross-functional teams and work effectively in a highly matrix team environment.
- Prior experience in establishing and defending raw material control strategy and associated raw material specifications with regulatory agencies.
- Proven track record of supporting or leading continuous improvement initiatives.
- Knowledge and use of basic statistical analysis methods
- Ability to influence others without direct authority and communicate with all levels of the organization.
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