Analytical Scientist

Job Description

• We are seeking a highly motivated, results-oriented, self-starter who demonstrates personal accountability for outcomes and thrives on increasing levels of responsibility, to join a new and dynamic team responsible for successful development and characterization of clinical-scale manufacturing processes for Chimeric Antigen Receptor T-cell (CART) therapies. 

• The successful candidate will help to develop and qualify appropriate analytical methods for the characterization, release and stability testing of CART products. 

• This position will also contribute to the development of Client technologies and approaches to meet future CART analytical needs and work in close collaboration with key stakeholders, including the CART Research and Analytical R&D groups.

Job Responsibilities: 

• Actively contribute to successful development, qualification and execution of robust, state-of-the-art analytical methods for characterization of CART manufacturing processes and products

• Provide analytical support for clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including qualification of in-process and release methods and tech transfer internally and externally in support of GMP manufacturing and release of clinical material.

• Contribute to relevant and impactful innovation programs to enhance CART characterization technologies and processes.

• Contribute to project technical teams to ensure effective integration at all levels. Communicate and collaborate effectively to ensure seamless interfaces and interactions with all stakeholder groups.

• Demonstrate strong personal leadership / accountability and technical as well as strong organizational and interpersonal skills, and apply sound scientific and technical experience to establish safe, high-quality lab practices.

• Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports and contribute to regulatory filings as appropriate.

• Present data/ strategy to scientists and management in internal and external venues (technical meetings, project team meetings, conferences) and publish in peer-reviewed journals, as appropriate.

Qualifications

BSc/ MSc or PhD degree in Immunology/ Molecular Biology with 5+ years of experience in biotech/ biopharma industry (preferably in the development of analytical methods for the characterization of gene- or cell-based therapies).

Industrial laboratory experience in a variety of analytical methods for the characterization and GMP release of cell-based or gene-therapies, especially cell-based and flow cytometry-based assays for the characterization/ release/ stability testing.

Applied skills in molecular immunology/ T cell biology/ primary T cell culture/ expansion and characterization.

Familiarity with cGMPs and relevant Regulatory Guidance documents.

Additional Information

Best Regards,

Anuj Mehta

973-967-3402