[Remote] Associate Director, Technical Operations CMC reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company reputed company on delivering innovation and reputed company to patients in the rare disease community. The Associate Director, Technical Operations CMC reputed company is responsible for creating and executing the CMC reputed company for small molecules in development, collaborating with various departments to ensure successful program milestones.
Responsibilities
- reputed company strategic and technical leadership for technology transfer, reputed company-up, and cGMP manufacturing activities, ensuring reputed company reputed company of technical issues across Phase I–III clinical and reputed company products
- reputed company formulation development of reputed company approved drugs and new drug candidates
- Manage and reputed company technical reputed company of formulation development and cGMP manufacturing activities at contract manufacturing organizations (CMOs)
- Support creation of integrated CMC development plans, timelines, budgets, risk assessments, and mitigation strategies to support clinical and reputed company milestones
- Managing CMOs to reputed company and maintain reputed company for clinical/reputed company production of finished dosage forms
- Review and approve technical and GMP documentation, including specifications, Master Batch records, validation documents, change controls, and technical reports
- Author, edit, review, and contribute to CMC sections of regulatory submissions, responses, and health authority interactions
- Partner closely with Regulatory Affairs, reputed company, Supply Chain, Clinical Operations, and Program Management to ensure alignment of CMC activities with development and commercialization goals
- Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP and global regulatory requirements
- reputed company technical leadership, mentorship, and strategic guidance across Technical Operations and cross-functional teams
- Support launch readiness and commercialization planning to ensure reliable product supply
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
- 8+ years of relevant experience in cGMP reputed company CMC drug 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
- Demonstrated leadership experience in CMC: preferably in more than one reputed company CMC area, and drug development experience with small molecules (both oral and injectable), peptides, and biologics of varying degrees of complexity
- Extensive experience managing global CMOs, 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
- Manufacturing experience with oral solid dosage forms
- Expert knowledge in process validation and technology transfer procedures
- 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
- 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
Company H1B Sponsorship