Senior Scientist, Analytical Lead (Immuno-Oncology)
Analytical Development - Greater Boston - Full Time
A cutting-edge biotech in the Greater Boston Area is seeking an Analytical Product Lead for there novel technology. This company is focused on developing transformative gene-based medicines for serious human diseases, such as hemoglobinopathies, cancer, diabetes and others, using their gene-editing platform into therapies.
This multi-disciplinary team of researchers and drug developers works every day to translate their technology into breakthrough human therapeutics. The lead program has entered clinical testing, and the immuno-oncology programs, have the potential to deliver a new generation of cancer therapies to patients.
About the position:
- Design, plan, advise, and monitor strategies for analytical development for all Immuno-oncology products.
- Lead, facilitate, and contribute to optimization of scientific/technical activities and processes within cell therapies development projects. Provide expertise for enhancing existing assays, and implementation of new ideas and technologies.
- Represent Analytics in the technical CMC project team.
- Advise/support in designing method qualification plans per ICH and regulatory guidelines.
- Collaborate with internal and external partners, CMOs to lead or monitor outsourcing activities and ensure deliverables.
- Cross-functional and highly visible position within Technical Operations group. Position requires active collaboration with research, process development and quality teams.
- MS/ Ph.D. in cell biology, immunology, molecular biology, or related sciences with 12+ (MS) or 5+ (Ph.D.) years of relevant industry experience required.
- Minimum 2 years of relevant hands-on experience in Analytical development and CMC of biologics is strictly required. Prior experience of IND, BLA or equivalent regulatory filings preferred.
- Strong knowledge of T-cell biology, immunology, analytical methods for cell and gene therapy products is required.
- Must have strong organization skills, and ability to multi-task in a fast-paced environment with changing priorities. Must be able to work effectively as part of a multi-disciplinary team.
- Must be independently motivated, detail oriented with good problem-solving ability.
This is a unique, highly technical position with a growing company dedicated to its employees and patients. Apply today!