Lead and support tech transfer of downstream purification processes to and within external partners, as part of a broader effort to ensure robust and scalable supply.
Execute and oversee downstream engineering runs and PPQ campaigns.
Serve as Person-in-Plant (PIP) during GMP manufacturing operations.
Provide technical leadership during investigations, deviations, and process excursions.
Drive alignment between Process Development and Manufacturing to ensure successful scale-up and execution.
Review batch records, SOPs, and technical reports to ensure manufacturing readiness.
Develop and implement risk mitigation strategies and control plans for purification processes.
Analyze process performance metrics including yield, impurity clearance, and product quality attributes.
Collaborate with AD and QC teams on method validation and characterization strategies.
Support preparation and review of CMC regulatory documentation related to downstream manufacturing.
Contribute to process robustness and lifecycle management strategies for commercial readiness.

B.S. or M.S. in Chemical Engineering, Bioprocess Engineering, Biotechnology, or related field
4+ years (Process Engineer) or 6–8+ years (Senior Process Engineer) in biologics downstream manufacturing
Direct experience with chromatography systems, filtration platforms, TFF, UF/DF, clarification, or purification of complex 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 mindset
Excellent communication and cross-functional collaboration skills
20–30% travel anticipated.

Senior Process Engineer, MSAT - Downstream

Key skills