
Associate Scientist, Analytical Ops - ddPCR Methods Development
美国 - 加利福尼亚州 - 圣莫尼卡产品开发和运营正式员工职位描述
We are looking for a highly motivated Associate Scientist to join our Method Development & Automation Team. This is a unique opportunity to join a highly innovative gene therapy company developing the next generation of CAR T therapies. You would have the opportunity to make significant contributions in our dynamic team where self-driven, enthusiastic employees thrive. In this role, the ideal candidate will leverage a diverse set of analytical tools to develop and refine robust methods that support the characterization and quality assessment of cell therapy products, ensuring accuracy, reliability, and compliance with regulatory standards to prioritize both efficacy and patient safety.
The ideal candidate will have hands-on experience in analytical method development utilizing molecular biology techniques, next-generation sequencing (NGS), and/or compendial methods. They will be responsible for designing, optimizing, and validating assays to assess product quality, purity, and functionality. The preferred candidate will have a strong understanding of method development concepts for enabling the development of robust analytical strategies to support regulatory and manufacturing needs.
Key Responsibilities
Perform molecular biology assays such as PCR, ddPCR, restriction digestion, and next-generation sequencing (NGS).
Analyze and interpret complex data to support method development and product characterization.
Collaborate with cross-functional teams to integrate analytical methods into manufacturing and regulatory workflows.
Author technical reports, SOPs, and validation documentation for regulatory submissions.
Ensure compliance with Good Documentation Practices (GDP), GMP, and quality assurance guidelines.
Author, review, and edit technical documents such as SOPs and/or reports
Basic Qualifications
- BS in Immunology, Biology, Cancer Biology or related discipline with 4+ years of experience OR
- MS in Immunology, Biology, Cancer Biology or related discipline with 2+ years of experience
Preferred Qualifications
3+ years of hands-on, industry experience with PCR (preferably ddPCR) methods development
Experience with data analysis software, such as MS Excel, PLA, JMP and SoftMax Pro.
Strong scientific writing and presentation skills
Ability to think critically and demonstrate troubleshooting and problem-solving skills
Highly collaborative with excellent interpersonal, verbal and written communication skills
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
Comfortable in a fast-paced small company environment with minimal direction