Associate Director, Process Development and Analytical Development
Location: Greater Boston area
Salary: $175,000 - $200,000
A small clinical Stage Biotechnology firm in the greater Boston area is looking to hire an associate director to join their CMC Process Development team. This role will give expertise in leading a team to support the process development of scalable mRNA synthesis. The ideal candidate will be able to perform in a team-oriented and fast-paced environment. This opportunity will allow career growth and a chance to lead the CMC Process Development and Analytical team.
Responsibilities
- Lead the CMC Process Development and Analytical team for mRNA - based drug substance.
- Modify and Conduct experiments to achieve desired outcomes and develop SOPs.
- Communicate research and development findings with the team.
- Establish process, release, and stability for mRNA therapeutics.
- Collaborate and manage outsourced vendors such as CDMOs.
- Oversee project timelines to ensure on time deliverables from the team.
- Contribute to the preparation of regulatory submissions, including data analysis for INDs and BLAs.
Requirements:
- PhD in Chemical engineering or related field with 6+ years of experience in analytical and process development
- Prior experience in leading a scientific team regarding analytical and process development.
- Excellent communication, problem-solving, and project management skills
- Strong background in biologics early and late-stage process development is highly preferred.
- Experience working cross functionally with the Drug Product department is highly valued.
- Experience with mRNA is preferred but not required.
