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VP/SVP CMC

Wellesley Hills, MA 01760

Posted: 01/11/2024 Employment Type: Direct Hire/Perm Job Number: 587766 Is job remote?: No Country: United States

Job Description

Our client is a cutting-edge Cell Therapy CAR-T company specializing in Oncology and Solid Tumor treatments. 
Position Summary: As the Vice President / Senior Vice President of CMC, you will play a pivotal role in overseeing all aspects of Chemistry, Manufacturing, and Controls for Cell Therapy CAR-T products. You will be responsible for process development, manufacturing, and quality control, driving the advancement of our novel therapies from early-stage development through to commercialization.

Key Responsibilities:

  • Strategic Leadership: Develop and execute CMC strategies aligned with the company's overall goals and objectives. Drive continuous improvement initiatives to enhance efficiency, quality, and scalability of manufacturing processes.

  • Regulatory Compliance: Ensure compliance with relevant regulatory guidelines, including FDA and other global health authorities. Lead interactions with regulatory agencies and oversee submissions related to CMC.

  • Process Development: Direct the development and optimization of robust and scalable cell therapy manufacturing processes, focusing on yield, purity, and product consistency.

  • Manufacturing Operations: Provide strategic direction and oversight for GMP-compliant manufacturing operations, including technology transfer, production planning, and supply chain management.

  • Quality Assurance and Control: Establish and maintain a rigorous quality management system. Drive a culture of quality and compliance throughout the organization.

  • Team Leadership and Development: Recruit, mentor, and lead a high-performing CMC team. Foster a collaborative and innovative work environment that encourages professional growth and development.

  • Cross-Functional Collaboration: Work closely with cross-functional teams including Research & Development, Clinical, Regulatory Affairs, and Commercial to ensure seamless integration of CMC activities with overall company objectives.

Qualifications:

  • PhD in a relevant scientific discipline (e.g., Chemical Engineering, Bioprocessing, Cell Biology, etc.) with a minimum of 10 years of experience in cell therapy CMC.

  • Proven track record of successfully leading CMC efforts for cell therapy programs, preferably in the CAR-T space.

  • In-depth knowledge of GMP regulations and industry best practices for cell therapy manufacturing.

  • Strong leadership and team-building skills, with the ability to inspire and motivate a diverse group of professionals.

  • Excellent communication and interpersonal skills, with the ability to effectively engage with internal teams, external partners, and regulatory authorities.

  • Strategic thinker with the ability to translate vision into actionable plans and drive results.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Wellesley Hills, MA

Ready to embark on your next career adventure in Wellesley Hills, Massachusetts? This picturesque town in Norfolk County is not only a vibrant hub of opportunities but also a charming place to call home. Known for its historic architecture, top-notch schools, and lush green spaces like Nehoiden Golf Course and Wellesley College's Botanic Gardens, Wellesley Hills offers a perfect blend of small-town charm and big-city amenities. Explore job opportunities in this unique community surrounded by landmarks like Longfellow's Wayside Inn, catch a show at the Wellesley Repertory Theatre, or savor the local cuisine at Blue Ginger before cheering for the Boston Celtics at TD Garden. Join us in Wellesley Hills and unlock your professional potential amidst a backdrop of rich culture and endless possibilities.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.