Process Engineer, Tech Transfer & Process Validation
Who We Are
ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary antibody-drug conjugate (ADC) technology. ImmunoGen’s lead product candidate, mirvetuximab soravtansine, is being advanced to a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen’s ADC technology is used in Roche's marketed product, Kadcyla, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about ImmunoGen can be found at www.immunogen.com.
ImmunoGen is seeking a Process Engineer, Tech Transfer & Process Validation to lead technology transfer and support manufacturing for synthetic small molecules (linkers and cytotoxic payloads), across all phases of development. The candidate will have extensive technical experience in the area of small molecule API processes. This includes hands-on experience with manufacturing and lab equipment and a solid understanding of process chemistry and engineering principles for scaling-up small molecule API processes. The candidate will have strong communication skills and build interfaces with the process chemistry group, the external manufacturing group, and quality organization. The successful candidate will report to the head of process engineering within the technical operations organization.
Responsibilities include (not limited to) the following:
- Leads process technology transfer of multiple programs spanning all phases of biopharmaceutical lifecycle. This will include discussions of equipment design and engineering as well as technical support of GMP manufacturing.
- Collaborate with process chemistry, including possible hands-on lab support during development, process characterization, and scale-up activities.
- Develop strong interfaces with the external manufacturing and quality organizations to provide technical support of manufacturing processes, as well as investigations and deviations.
- Lead and document risk assessments (process change, raw material, facility fit, etc.) to support technology transfer.
- Support preparation of transfer documentation including process descriptions, sampling plans and technical protocols as well as assist in coordination of scale up and engineering runs for API manufacturing and lead the evaluation of scale up performance
- In collaboration with manufacturing and development, support efforts to improve process scalability and robustness.
- Review process validation documentation, master batch records and transfer protocols/reports.
- Compile, trend, and analyze process data from ongoing experiments and manufacturing campaigns and generate technical reports, as required.
- Contribute to regulatory filings, as required.
- Travel may be required in support of tech transfer activities.
Who You Are
- B.S. with 6+ years (M.S. 4+ years) of related experience in Chemical Engineering, Chemistry, Organic Chemistry, or related field.
- In-depth understanding of process chemistry and API process scale-up and associated engineering principles, as well as at-scale manufacturing processes and equipment experience
- Experience with process validation is preferred
- Candidate must demonstrate ability to effectively communicate with external manufacturing partners
- Direct experience in authoring & reviewing CMC sections for regulatory filings is preferred
- Experience in working with and managing external manufacturing partners is preferred
- Self-directed: an individual who is able to work effectively with limited direction in a complex, fast-paced environment
ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.