Process Engineer

Process Engineer at Talent Groups Process Engineer at Talent Groups in Chelsea, Massachusetts Posted in about 20 hours ago.

Type:

full-time

Job Description:

Job Description The Senior Process Engineer supports drug substance technology transfers across 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.

You will be responsible for:

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.