Analytical Scientist, Analytical Development

Ensoma - Boston, MA

Full-time - Senior

Boston, MA

About the position

The Analytical Scientist in Analytical Development at Ensoma will focus on cell-based assay development within the Chemistry, Manufacturing, and Controls (CMC) team. This role involves a variety of analytical development tasks, including assay development, troubleshooting, and method optimization to assess and characterize viral vectors. The position offers a unique opportunity to contribute significantly to advancing a novel gene therapy drug candidate through in-lab research and collaboration with vector production and process development teams.

Responsibilities

• Utilize multiple techniques from cellular biology, biochemistry, and molecular biology to build an analytical potency platform.
• Lead the development of robust assays in support of drug substance and drug product manufacturing and release testing.
• Independently drive assay development, optimization, and CDMO-transfer related activities including troubleshooting and data review.
• Provide regular updates to method stakeholders in writing and through technical presentations; represent analytical development in cross-functional teams.
• Maintain accurate records, including writing technical reports detailing procedures, outcomes, and data analysis.
• Manage and review experiments and studies performed by team members.

Requirements

• A PhD in Life sciences, Biology, Cell Biology, Molecular Biology, Biochemistry, or related field with a minimum of 2 years of industry experience, or a Master's Degree in a similar field with a minimum of 4 years of experience.
• Depth of knowledge and recent industry experience performing potency assay development, gene and protein expression analysis, and viral particle characterization for cell and gene therapies.
• Demonstrated ability to apply relevant techniques and problem-solving skills with various assays, such as PCR, ELISA, flow cytometry, cell-based assays, ligand-binding assays, and infectivity assays.
• Advanced scientific/technical expertise to implement innovative solutions in industrial settings.
• Commitment to maintaining scientific integrity and meticulous Good Documentation Practices (GDP) record keeping.
• Organizational skills to support managing multiple projects in parallel and prioritizing tasks.

Nice-to-haves

• Proficiency with laboratory automation and high throughput screening platforms.
• Expertise in developing and qualifying analytical methods to support product development and regulatory filings, preferably for gene and/or cell therapy products.
• Successfully transferred and/or supported potency assays to GxP laboratories.
• Understanding of relevant GxP guidelines (manufacturing, documentation, etc.).
• Exceptional listening skills with the ability to seek constructive feedback, build relationships, promote teamwork, and remain flexible, humble, and open-minded.

Benefits

• Competitive salary range of $105K - $133K per year.
• Opportunity to work on innovative gene therapy projects.
• Collaborative and supportive work environment focused on professional development.