GondolaBio · 2 months ago
Associate/Director, Analytical Development
Palo Alto, CA
Full-time
Hybrid
Lead/Staff, Director/Executive
$188K/yr - $213K/yr
10+ years expGondolaBio is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for genetic diseases. The Associate/Director of Analytical Development will be responsible for providing analytical and bioanalytical strategy for small molecule candidates and peptides from Phase I through NDA, as well as managing stability programs for drug substances and products.
BiotechnologyManufacturingPharmaceutical
Responsibilities
Guide CRO/CDMO to design and perform method development and validation employing phase-appropriate approaches at different stages of development (pre-clinical through Phase 3) for assay, purity and dissolution methodologies, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization
Develop phase-appropriate quality control strategy for drug substance and drug products
Manage product stability study programs
Guide CRO to develop and validate GLP bioanalytical methods to support DMPK, Toxicology and clinical studies
Author analytical development and validation reports and analytical sections in IND/IMPD and NDA filings
Precise coordination with QA and Regulatory, as well as other CMC functions, clinical and toxicology, regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing
Serve as the Analytical representative in cross functional project teams
Interface effectively with other disciplines (e.g., Clinical, Nonclinical, Drug Substance, Quality Assurance, and CDMO Quality Control)
Qualification
Required
PhD in analytical chemistry with 10+ years of analytical development experience in the pharmaceutical industry
Excellent scientific knowledge in analytical chemistry
Demonstrate a proven track record of managing CROs and CDMOs, preferably on both analytical and bioanalytical projects, in developing methods and quality control strategy for testing of small molecule drug candidates supporting Phase I to commercial launch
Experience in drafting analytical sections of IND/IMPD and NDAs
Experience in drafting, reviewing and submitting required documentation pertaining to the cGMP and GLP environment
A proven track record of implementing phase appropriate quality control strategies
Strong knowledge of US FDA, EMEA and ICH guidelines is a must
Preferred
Experience with Peptides a plus
Experience working in a QC environment a plus
Benefits
Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
Flexible PTO
Rapid career advancement for strong performers
Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time
Partnerships with leading institutions
Commitment to Diversity, Equity & Inclusion
Company
GondolaBio
GondolaBio researches, develops and manufactures pharmaceutical products. It is a sub-organization of BridgeBio.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$300M2024-08-16Series Unknown· $300M
Leadership Team
J
James Li
President
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