Scientist, Analytical DevelopmentWe are seeking a highly motivated and driven Analytical Scientist, Analytical Development to join the Chemistry, Manufacturing, and Controls (CMC) team at Ensoma to focus on cell-based assay development. . This role will be integrated into a wide variety of Analytical Development tasks, including assay development, assay troubleshooting, and method optimization to assess and characterize viral vectors. This position will provide exposure to Ensoma's vector production and process development teams by performing analytical testing to drive process modifications and development path decisions, with a specific focus on cell-based assays. This is a unique opportunity to play a significant role in advancing a novel gene therapy drug candidate into the clinic through significant in-lab research.
Responsibilities:Utilize multiple techniques from fields including 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.
Qualifications:Required
- A PhD in Life sciences, Biology, Cell Biology, Molecular Biology, Biochemistry, or related field with experience in biotechnology, pharmaceutical, or academic settings 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 in biotechnology, pharmaceutical and/or academic settings.
- 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, enzyme-linked immunoassay (ELISA), flow cytometry, cell-based assays, ligand-binding assays, infectivity assays, etc.
- Innate interest in problem solving and applying critical thinking to resolve complex questions; able to deliver clear written and verbal communications to peers and colleagues.
- 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.
Preferred
- 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.
- PhD and 3 or more years of industry experience performing potency method development
- About Ensoma:
- Ensoma is a place where you can ask the big questions. We look at gene therapy today and ask: What if we could eliminate the patient burden? What if we could treat diseases that affect millions? What if we could treat people anywhere around the world?
Ensoma was founded to answer these questions through our Engenious™ platform that can transform the hematopoietic (blood & immune) system with a single treatment. Our Engenious gene therapy platform is the first to precisely engineer any or all hematopoietic and immune cells with a one-time, off-the-shelf in vivo treatment. Engenious therapies have an unmatched capacity to deliver all modern genetic modification tools and set a new standard for versatile cell programming and control across a range of complex diseases. We believe the future of medicine lies within us - and this bigger, bolder vision for gene therapy needs incredible people to make it a reality.For our team, realizing this vision is personal. Founded and guided by leaders drawn from the top of the cell and gene therapy field, we feel an urgency and passion for our work driven by its potential global impact. A meeting at Ensoma is a space where curiosity, trust, authenticity, problem-solving and professional development are celebrated. A career at Ensoma is an opportunity to be part of the team building the future of medicine.Ensoma is supported by top-tier investors, a strategic collaboration with Takeda and a passionate team committed to a bold global vision for gene therapy. Ensoma is based in Boston, Massachusetts. For more information, please visit www.ensoma.com.