[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 reputed company development and manufacturing partners
• Advanced degree (M.S., Ph.D., Pharm.D., or equivalent)

reputed company