Director, Analytical Development — DMPK & Stability
GondolaBio
Palo Alto (CA)
Hybrid
USD 188,000 - 213,000
Full time
14 days+
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Benefits offered by this job
Flexible PTO
Robust benefits package
Rapid career advancement
Diversity and Inclusion commitment
Job summary
A clinical-stage biopharmaceutical company in California seeks an experienced Associate/Director of Analytical Development to lead analytical strategies for small molecules. The role demands a PhD in Analytical Chemistry and over 10 years of relevant experience. Responsibilities include managing CROs, developing quality control strategies, and collaborating with cross-functional teams. This position offers competitive compensation and a supportive, fast-paced work environment focused on patient impact.
Qualifications
10+ years of analytical development experience in pharmaceutical industry.
Proven track record in managing CROs and CDMOs.
Strong knowledge of US FDA, EMEA and ICH guidelines.
Responsibilities
Provide analytical and bioanalytical strategy for small molecule candidates.
Develop phase-appropriate quality control strategy for drug substances.
Guide CROs in method development and validation.
Skills
Analytical Chemistry
CRO/CDMO Management
Scientific Knowledge
FDA Guidelines
Quality Control Strategy
Education
PhD in Analytical Chemistry
Job description
A clinical-stage biopharmaceutical company in California seeks an experienced Associate/Director of Analytical Development to lead analytical strategies for small molecules. The role demands a PhD in Analytical Chemistry and over 10 years of relevant experience. Responsibilities include managing CROs, developing quality control strategies, and collaborating with cross-functional teams. This position offers competitive compensation and a supportive, fast-paced work environment focused on patient impact.