ImmunoGen is seeking a Scientist/Sr. Engineer to join the process development team. This person will develop robust ADC conjugation processes that chemically couple ImmunoGen’s active payloads molecules to tumor targeting molecules. He/she will be an independent contributor within the process development group and will work with ImmunoGen’s network of outsourced vendors and contract manufacturers. This position offers the opportunity to work in a fast-paced, dynamic environment with interaction across groups within the entire Technical Operations organization. The successful candidate will be motivated to work independently, possess excellent time management and communication skills, and will play a key role in the process development of anticancer therapeutics.
Responsibilities include (not limited to) the following:
- Serve as a key subject matter expert in ADC process development bridging process development and cGMP manufacturing
- Oversee and collaborate with external organizations to generate research ADCs for use in exploratory non-clinical studies
- Utilize process design, design of experiments (DoE), and other engineering principles to design efficient studies that enable early-phase development of robust processes suitable for process transfer and cGMP manufacturing.
- Working collaboratively within a multi-disciplinary team, composed of analytical, process development, process engineering, and external manufacturing functions
- Serving as a process development representative on cross-functional teams to ensure all stake-holders are informed
- Communicating scientific results in a clear, concise, and accurate manner via report preparation, conference presentations, regulatory filings, and via participation in team meetings
- Interface with regulatory department and define clear expectations of final work product
- Engaging in and contributing to industry advances through attendance at scientific conferences and publishing
Who You Are:
- M.S or B.S. in Chemistry, Chemical Engineering, Biochemistry, Bioengineering, or related field with 8+ years of relevant experience. Ph.D. in in Chemistry, Chemical Engineering, Biochemistry, Bioengineering, or related field with at least 2 years of relevant experience will also be considered
- Demonstrated laboratory, critical thinking, and problem solving skills with a track record of innovation and academic or industry achievement (i.e. peer reviewed scientific publications and/or patents)
- Motivated, self-directed, and detail-oriented with the ability to operate effectively in a complex, fast-paced environment
- Prior experience in process development is required
- Prior experience in ADC process design, process characterization, scale-up, and process transfer is preferred
- Experience with external vendors and oversight of contract organizations is a plus.
- Understanding of Quality by Design (QbD) principles and statistical software (JMP) are a plus
- Able to multi-task and function effectively in a dynamic environment involving alignment and prioritization, with adaptability to changing business needs, requirements and priorities