[Remote] Associate Director, Technical Operations CMC reputed company (Remote)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an Associate Director for Technical Operations CMC reputed company to reputed company the CMC reputed company for small molecules in development. The role involves collaboration with various departments to ensure reputed company and compliant manufacturing and development processes.
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
reputed company
Company H1B Sponsorship