ASSOCIATE DIRECTOR, TECHNICAL OPERATIONS – DRUG PRODUCT (REMOTE)

Associate Director, Technical Operations – Drug Product (Remote)

Location: San Diego, California

Category: Scientific

Salary: Apply for details

Country: United States

Employment: Direct Hire/Perm

Worksite: On-Site

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Job Description

Position Summary:

The Associate Director, Technical Operations – Drug Product, is responsible for drug product manufacturing, scale up, validation, and commercialization of a small molecule, solid oral drug product. The successful candidate enjoys managing external CDMOs and collaborating closely with colleagues in Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain. This position is a key CMC contributor for the clinical development through the commercialization of a small molecule drug product for a rare disease indication.

Responsibilities

• Technical oversight of production, scale up, process characterization, and process performance qualification (PPQ) of drug product manufacture of a small molecule, solid oral product at company CDMOs.
• Review and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
• Verify suitability, qualification, and validation of processes at CDMOs and other external laboratories.
• Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
• Collaborate on CMC development and commercialization of drug product with internal and external project teams.
• Author and review technical documents and regulatory filings, including INDs, IMPDs, and NDAs.
• Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production.
• Review project scope and ensure that contractual obligations of CDMOs meet quality standards and timelines.
• Provide technical recommendations to leadership regarding CDMO performance, process readiness, validation strategy, regulatory risks, and commercialization milestones.
• Additional duties assigned as needed.
  
  

Education/Experience Requirements

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or other related discipline required. Equivalent combination of education and applicable job experience may be considered. Advanced degree, M.S., or Ph.D. degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or other related disciplines is preferred.
• 8 years of relevant work experience including small molecule drug product manufacturing with a focus on scale-up, late phase clinical development, and commercialization.
• Manufacturing experience with amorphous solid dispersions (spray dried amorphous dispersions preferred); solid oral drug product (granulation, capsules and tablets) development experience a plus.
• Expert knowledge in process development, characterization studies, PPQ, and commercialization for solid oral products, with emphasis on amorphous solid dispersions.
• 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.
  
  

Additional Skills/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 is a plus.
  
  

Comp based on experience/level $150,000.00 – $195,000.00 range

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.