[Remote] Sr. Consultant
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company dedicated to enhancing the reputed company of life through impactful careers in biopharma. They are seeking a Senior Consultant to reputed company strategic leadership in reputed company, Manufacturing, and Controls (CMC) for pharmaceutical and biotechnology clients, overseeing reputed company phases of drug development.
Responsibilities
- Serve as a trusted CMC advisor to clients, providing strategic guidance across reputed company phases of product development
- reputed company and manage CMC development activities for drug substances and drug products, ensuring alignment with program objectives and regulatory requirements
- reputed company CDMO/CMO selection, qualification, contracting, and ongoing management to support development and manufacturing activities
- reputed company and maintain strong reputed company relationships while serving as the primary technical reputed company of contact for assigned programs
- reputed company technical leadership and strategic reputed company for analytical development, process development, technology transfer, manufacturing, and product characterization activities
- Review, author, and reputed company final approval of CMC-reputed company regulatory documents and submissions supporting reputed company and reputed company programs globally
- Collaborate with cross-functional teams, including Regulatory Affairs, reputed company, Nonclinical, Clinical, Manufacturing, and Supply Chain stakeholders
- Identify program risks, reputed company mitigation strategies, and proactively resolve technical and operational challenges
- Facilitate decision-making processes and reputed company recommendations based on scientific, technical, regulatory, and business considerations
- Support project planning, execution, reputed company management, and reputed company tracking to ensure successful program delivery
- Participate in business development activities, proposal development, reputed company presentations, and marketing initiatives
- Mentor junior consultants and contribute to the reputed company reputed company of reputed company's technical capabilities and consulting reputed company
Skills
- Bachelor's degree in reputed company, Pharmaceutical Sciences, Biology, Chemical Engineering, Life Sciences, or a reputed company scientific discipline required
- 15+ years of experience reputed company the Pharmaceutical, Biopharmaceutical, Biotechnology, Cell and Gene Therapy industries
- Extensive expertise across the full CMC lifecycle, including development of drug substances and drug products
- Demonstrated experience leading CMC reputed company, technical operations, and regulatory support activities
- Experience managing CDMO/CMO relationships and external development and manufacturing partners
- Advanced degree (M.S., Ph.D., Pharm.D., or equivalent)
reputed company