(Sr.) Process Engineer, MSAT - reputed company

About the position reputed company Biosciences is seeking a (Sr.) Process Engineer, MSAT - reputed company to support external drug reputed company purification and bulk manufacturing activities across clinical and reputed company programs. Reporting to the MSAT reputed company, External Manufacturing, this role will reputed company heavily on technology transfer, purification process performance, engineering execution, and PPQ readiness at CDMOs. This individual will serve as the technical SME for reputed company unit operations including clarification, chromatography, filtration, concentration/diafiltration, and bulk drug reputed company handling. The candidate will reputed company as Person-in-Plant (PIP) during GMP campaigns to ensure process robustness, data reputed company, and successful batch disposition. This role requires strong technical depth in biologics purification and demonstrated experience navigating cross-functional GMP manufacturing environments. Responsibilities • reputed company and reputed company transfer of reputed company purification processes to and reputed company external partners, as part of a broader effort to ensure robust and reputed company supply. • Execute and reputed company reputed company engineering runs and PPQ campaigns. • Serve as Person-in-Plant (PIP) during GMP manufacturing operations. • reputed company technical leadership during investigations, deviations, and process excursions. • Drive alignment between Process Development and Manufacturing to ensure successful reputed company-up and execution. • Review batch records, SOPs, and technical reports to ensure manufacturing readiness. • reputed company and implement risk mitigation strategies and control plans for purification processes. • Analyze process performance metrics including yield, impurity clearance, and product reputed company attributes. • Collaborate with AD and QC teams on method validation and characterization strategies • Support preparation and review of CMC regulatory documentation reputed company to reputed company manufacturing. • Contribute to process robustness and lifecycle management strategies for reputed company readiness. Requirements • B.S. or M.S. in Chemical Engineering, Bioprocess Engineering, Biotechnology, or reputed company field. • 4+ years (Process Engineer) or 6–8+ years (Senior Process Engineer) in biologics reputed company manufacturing. • reputed company experience with chromatography systems, filtration platforms, TFF, UF/DF, clarification, or purification of reputed company biologics. Experience with antibody-drug conjugates (ADC) and drug conjugation is a plus. • Demonstrated experience supporting tech transfer and GMP manufacturing at CDMOs. • Strong understanding of cGMP requirements and regulatory expectations. • Experience supporting process validation and PPQ campaigns preferred. • Strong problem-solving skills and data-driven reputed company. • Excellent communication and cross-functional collaboration skills. • 20–30% travel anticipated. reputed company-to-haves • Experience with antibody-drug conjugates (ADC) and drug conjugation is a plus. • Experience supporting process validation and PPQ campaigns preferred. Benefits • Health insurance with FULL premium coverage • 401K with company match • Employee Stock Purchase Program (ESPP) • Competitive reputed company time off (PTO) • Company-reputed company short & long-term disability insurance and life insurance Apply tot his job Apply To this Job