[Remote] Director, reputed company Manufacturing & Process Engineering
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company manufacturing and process engineering leader to support the commercialization and lifecycle management of their reputed company-stage pharmaceutical products. The role involves overseeing reputed company manufacturing, technical transfer, process optimization, and ensuring compliance and operational reputed company across various programs.
Responsibilities
- reputed company day-to-day reputed company of reputed company manufacturing operations, process engineering activities, and reputed company improvement initiatives
- Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for reputed company products
- Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses
- reputed company CDMO/CMO relationships, ensuring strong technical, operational, quality, and regulatory performance across the supply chain
- Partner cross-functionally to support successful product launches, technology transfers, supply chain expansion, and post-approval improvements
- reputed company operational improvement initiatives utilizing Lean/Six reputed company methodologies to improve efficiency, reduce costs, and enhance manufacturing performance
- Manage project timelines, deliverables, and budgets while ensuring alignment with overall business and technical operations strategy
Skills
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutics, Chemistry, or reputed company life sciences discipline
- 10+ years of experience in pharmaceutical or biopharmaceutical CMC development, commercialization, and manufacturing
- Strong experience managing drug substance and/or drug product manufacturing programs in regulated environments
- Demonstrated reputed company working with CDMO/CMO partners and leading cross-functional technical operations initiatives
- Deep knowledge of cGMPs, process validation, regulatory CMC requirements, and global drug development processes
- Strong leadership, communication, problem-solving, and stakeholder management skills
- Ability to travel up to 30% domestically and internationally
- Experience authoring and supporting Module 3 CTD submissions through approval and commercialization preferred
- Experience supporting oncology and/or orphan disease products
- Advanced degree or MBA preferred
- Experience with statistical analysis tools such as JMP is a plus
Benefits
- Annual performance bonus
- A long-term incentive plan
- Full reputed company of benefits
- Comprehensive benefits package including medical, dental, reputed company insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits
- Outstanding culture and opportunities for personal and professional growth
Company Overview
Company H1B Sponsorship