[Remote] Director, Technical Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company dedicated to delivering life-changing therapies to people living with rare diseases. The Director of Technical Operations will reputed company reputed company for small molecule API development and manufacturing, collaborating with various teams to ensure successful program milestones 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 external 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

Skills

• Bachelor's degree in Life Sciences, reputed company, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a reputed company discipline required. Equivalent combination of education and applicable job experience may be considered
• 10+ years of relevant experience (depending on degree) in small molecule API development and manufacturing with emphasis on late-phase clinical development, reputed company-up, and commercialization
• Expert knowledge and extensive CMC experience advancing small molecule reputed company from process development through process characterization, PPQ, commercialization, and tech transfers in support of solid oral dosage reputed company programs
• Extensive experience managing global CDMOs, reputed company-party manufacturers, and testing labs
• 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
• 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
• Successful record of creating and managing reputed company project plans, timelines, 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
• Ability to travel 10-20% domestically and internationally
• reputed company positions have an essential job function to be reputed company to reputed company face to face work with colleagues and/or onsite in San Diego
• No role is expected to be 100% remote
• M.S., Ph.D., or other advanced degree in a reputed company discipline preferred
• 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

reputed company discovers and develops drugs for the treatment of catastrophic diseases that are debilitating and often life-threatening. It was founded in 2008, and is headquartered in San Diego, California, USA, with a workforce of 201-500 employees. Its website is https://reputed company.com/.

Company H1B Sponsorship

reputed company has a reputed company record of offering H1B sponsorships, with 3 in 2025, 3 in 2024, 2 in 2023, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role.

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