People With Chemistry
Associate Director Analytical Development Small molecule
People With Chemistry, Hayward, California, us, 94557
This role is based in the SF Bay Area. We are considering candidates seeking relocation.
Summary
We are partnered with a clinical-stage biotech based in the East Bay focused on developing innovative cancer immunotherapies. We are seeking an
Associate Director of Analytical Development
to lead analytical strategy and execution for small molecule drug substance and drug product development. This onsite role is part of the Pharmaceutical Development & Manufacturing team and involves oversight of laboratory and CDMO analytical activities. The ideal candidate brings deep technical expertise, regulatory experience, and a collaborative mindset to support programs from early development through to commercial readiness.
Job Responsibilities
Lead method development, impurity characterization, and analytical testing for small molecule programs Oversee CDMO and CRO analytical activities including method validation, transfer, and stability testing Perform or supervise in-house testing in support of formulation and process development. Author and review technical reports, regulatory documentation (e.g., IND, NDA), and specifications Collaborate with cross-functional CMC, QA, and Regulatory teams to meet development and filing milestones Job Requirements
PhD (7+ yrs), MS (9+ yrs), or BS (11+ yrs) in chemistry or related field with relevant industry experience Proven expertise in chromatography (HPLC), dissolution, and small molecule analytical methods; mass spectrometry experience preferred Strong knowledge of GMP, ICH guidelines, and regulatory requirements across development phases Experience supporting late-phase programs and authoring regulatory submissions Excellent communication, technical writing, and project management skills in a fast-paced environment
Contact:
Reach out to Amit at amit.uma@meetlifesciences.com to have a confidential discussion and learn more.
Summary
We are partnered with a clinical-stage biotech based in the East Bay focused on developing innovative cancer immunotherapies. We are seeking an
Associate Director of Analytical Development
to lead analytical strategy and execution for small molecule drug substance and drug product development. This onsite role is part of the Pharmaceutical Development & Manufacturing team and involves oversight of laboratory and CDMO analytical activities. The ideal candidate brings deep technical expertise, regulatory experience, and a collaborative mindset to support programs from early development through to commercial readiness.
Job Responsibilities
Lead method development, impurity characterization, and analytical testing for small molecule programs Oversee CDMO and CRO analytical activities including method validation, transfer, and stability testing Perform or supervise in-house testing in support of formulation and process development. Author and review technical reports, regulatory documentation (e.g., IND, NDA), and specifications Collaborate with cross-functional CMC, QA, and Regulatory teams to meet development and filing milestones Job Requirements
PhD (7+ yrs), MS (9+ yrs), or BS (11+ yrs) in chemistry or related field with relevant industry experience Proven expertise in chromatography (HPLC), dissolution, and small molecule analytical methods; mass spectrometry experience preferred Strong knowledge of GMP, ICH guidelines, and regulatory requirements across development phases Experience supporting late-phase programs and authoring regulatory submissions Excellent communication, technical writing, and project management skills in a fast-paced environment
Contact:
Reach out to Amit at amit.uma@meetlifesciences.com to have a confidential discussion and learn more.