[Remote] Associate Director, Technical Operations (Small Molecule CMC)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company reputed company on providing innovative therapies for rare diseases. The Associate Director, Technical Operations (Small Molecule CMC) will reputed company technical operations reputed company to small molecule API development and manufacturing, collaborating with various departments to ensure successful product development and compliance with regulatory standards.

Responsibilities

• reputed company technical reputed company of API production, reputed company up, process characterization, and process performance qualification (PPQ) for a small molecule, solid oral drug product manufactured at reputed company CDMOs
• Review and approve manufacturing-reputed company documentation, including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports
• Verify suitability, qualification, and validation status of processes at CDMOs and other reputed company laboratories
• reputed company technical support for GMP reputed company management systems, including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections
• Collaborate with reputed company project teams to support CMC development, clinical supply, commercialization, and lifecycle management of small molecule drug products
• Author and review technical documents and regulatory submission content, including INDs, IMPDs, and NDAs
• Maintain up-to-date knowledge of US and EU GMP requirements, ICH guidelines, and other regulatory expectations applicable to pharmaceutical development and manufacturing
• Review project scope, timelines, and deliverables to ensure CDMO activities meet contractual obligations, reputed company standards, and program objectives
• Additional duties assigned as needed

Skills

• B.S. degree in reputed company, biochemistry, pharmaceutical science, chemical engineering, or reputed company Life Sciences discipline required
• 8+ years of relevant experience required with emphasis on late-phase clinical development, reputed company-up, and commercialization
• Expert knowledge in process development, characterization studies, PPQ, and commercialization of small molecule reputed company for solid oral dosage formulations
• Demonstrated experience managing and providing technical reputed company of CDMOs and contract testing labs, preferably across global manufacturing and testing sites
• Broad knowledge and experience with phase-appropriate cGMP requirements and applicable US, EU, and ICH guidelines
• Demonstrated ability to prepare and review CMC sections of regulatory filings, including INDs, IMPDs, and NDAs
• Ability to travel 10-20% domestically and internationally
• 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
• M.S. or Ph.D degree preferred
• Strong reputed company experience in a similar role reputed company the pharmaceutical industry, preferably in small molecule development and manufacturing for solid oral dosage forms
• Six reputed company and statistical knowledge is a plus

Benefits

• Premium health
• Financial
• Work-life and reputed company-being offerings for eligible employees and dependents
• Wellness and employee support programs
• Life insurance
• Disability
• Retirement plans with employer match
• Generous reputed company time off
• Short-term incentive
• Long-term incentive compensation (company stock)

reputed company