Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
true
VP/SVP CMC
Posted: 01/11/2024
2024-01-11
2024-04-18
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:
Qualifications:
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:
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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.
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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.
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Process Development: Direct the development and optimization of robust and scalable cell therapy manufacturing processes, focusing on yield, purity, and product consistency.
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Manufacturing Operations: Provide strategic direction and oversight for GMP-compliant manufacturing operations, including technology transfer, production planning, and supply chain management.
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Quality Assurance and Control: Establish and maintain a rigorous quality management system. Drive a culture of quality and compliance throughout the organization.
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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.
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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:
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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.
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Proven track record of successfully leading CMC efforts for cell therapy programs, preferably in the CAR-T space.
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In-depth knowledge of GMP regulations and industry best practices for cell therapy manufacturing.
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Strong leadership and team-building skills, with the ability to inspire and motivate a diverse group of professionals.
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Excellent communication and interpersonal skills, with the ability to effectively engage with internal teams, external partners, and regulatory authorities.
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Strategic thinker with the ability to translate vision into actionable plans and drive results.
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