SENIOR ENGINEER/SCIENTIST II, DRUG PRODUCT

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology.

ImmunoGen is seeking a dynamic and motivated Senior Engineer who will join the Drug Product & Process Analytics team and play a key role in the development and commercialization of our Antibody Drug Conjugates (ADCs).

• Develop processes at lab scale for drug product unit operations such as freeze-thaw, compounding, mixing, sterile filtration, filling, capping, visual inspection, and transportation.
• Develop lyophilization cycles for freeze-dried drug products, perform optimization of lyo cycle, and scale up the process to production scale.
• Lead and/or support technology transfer teams for transferring the fill-finish processes to external CMOs.
• Perform equipment fit/facility fit analysis and provide technical support for equipment selection/design/review.
• Develop and maintain relationships with external partners.
• Provide person-in-plant support for at scale studies, engineering runs, and production runs.
• Provide technical support for manufacturing deviations, change controls, and corrective and preventive actions.
• Author and/or review technology transfer protocols, master batch records, SOPs, specifications, equipment qualification protocols/reports, and process performance qualification protocols/reports.
• Perform process characterization of fill-finish unit operations at lab scale and production scale using QbD principles.
• Perform process risk assessments such as FMEAs to identify failure modes and recommend mitigation strategies.
• Provide technical support for the validation of aseptic processes, filter validation, cleaning validation, equipment validation, and process validation.
• Perform process monitoring of production batches using appropriate statistical tools and identify improvement opportunities.
• Author and/or review relevant CMC sections of various Regulatory submissions.
• Lead and /or participate in CMC drug product sub-teams for ImmunoGen’s internal programs.
• Collaborate closely with other CMC team members and functional areas such as Analytical & Pharmaceutical Sciences, QA, QC, Project Management, Regulatory, etc.

• BS/MS in Chemical/Biochemical Engineering/Pharmaceutical Sciences with 6-8 years of experience (or PhD with 4 years of experience) in the biopharmaceutical industry with drug product process development/manufacturing operations for liquid as well as lyophilized drug products.
• Experience in late stage drug product process development, process characterization, and process validation is preferred.
• Experience in technology transfer of sterile liquid and lyophilized drug products and management of contract manufacturers is preferred.
• Knowledge of global ICH/GMP regulations and guidance is preferred.
• Experience in leading cross-functional teams and project management is preferred.