Associate Director, Technical Operations - Drug Product
$150,000–$195,000 year
HybridSan Diego, California, United States
Job Summary
Oversee production, scale-up, and process characterization of small molecule solid oral drug products at external CDMOs. Review and approve manufacturing documents including change notifications, batch records, and validation protocols. Verify suitability of processes at third-party facilities and provide technical support for GMP quality systems, deviations, and CAPAs. Collaborate with internal teams on CMC development, commercialization, and regulatory filings for INDs, IMPDs, and NDAs. Manage CDMO contractual obligations and provide leadership recommendations on validation strategies and commercialization milestones. Requires 8+ years in small molecule drug product manufacturing with expertise in amorphous solid dispersions. Full-time role with 10-20% travel; onsite presence in San Diego required.
Required Qualifications
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or other related discipline
- 8+ years of relevant work experience including small molecule drug product manufacturing with a focus on scale-up, late phase clinical development, and commercialization
- Expert knowledge in process development, characterization studies, PPQ, and commercialization for solid oral products
- Skilled in preparation of CMC modules of regulatory filings such as INDs, IMPDs, and NDAs
- Extensive experience managing global CDMOs and/or third-party manufacturers and testing labs
- Broad knowledge and experience with phase-appropriate cGMP requirements and US, EU, and ICH guidelines
- Ability to travel 10-20% domestically and internationally
- All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
Desired Qualifications
- Advanced degree, M.S., or Ph.D. degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or other related disciplines
- Manufacturing experience with amorphous solid dispersions (spray dried amorphous dispersions preferred)
- Solid oral drug product (granulation, capsules and tablets) development experience
- Strong professional experience in a similar role within the pharmaceutical industry, preferably in small molecule solid oral development and manufacturing
- Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
- Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills
- Excellent decision-making and collaboration skills with strong attention to detail
- Six Sigma and statistical knowledge
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