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.
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