Vice President of CMC Biologics
Hybrid
Company Overview:
We are partnered with an emerging Biotechnology company focused on developing Best-in-class Therapeutics to address unmet medical needs. This leading Biopharma has several assets across multiple stages of development and are on track to hit multiple milestones H2 of this year.
Job Summary:
We are seeking a highly experienced and strategic leader to join our team as the Vice President of CMC (Chemistry, Manufacturing, and Controls) Biologics. The VP of CMC Biologics will be responsible for overseeing all CMC activities related to the development, manufacturing, and regulatory compliance of biologic products. This role requires a deep understanding of biologics, regulatory requirements, and the ability to lead cross-functional teams to ensure the successful development and commercialization of biologic therapies.
Key Responsibilities:
- Develop and implement CMC strategies for biologic products from early development through commercialization.
- Lead and mentor a team of CMC professionals, fostering a collaborative and high-performance culture.
- Provide strategic direction and oversight for all CMC activities, including process development, analytical development, and manufacturing.
- Ensure compliance with global regulatory requirements for biologics, including the preparation and submission of CMC sections for regulatory filings (INDs, BLAs, etc.).
- Stay current with regulatory guidelines and industry best practices to ensure the company's CMC activities are aligned with regulatory expectations.
- Oversee the development and optimization of manufacturing processes for biologic products from IND-enabling to Late Stage/Commercialization
- Collaborate with internal and external stakeholders to resolve technical challenges and ensure the successful scale-up and transfer of manufacturing processes.
- Work closely with the Quality Assurance and Manufacturing teams to ensure the production of high-quality biologic products.
- Implement and maintain cGMP (current Good Manufacturing Practices) standards across all CMC activities.
- Drive continuous improvement initiatives to enhance product quality, efficiency, and compliance.
- Collaborate with R&D, Clinical, Regulatory Affairs, and Commercial teams to align CMC activities with overall product development and commercialization strategies.
- Provide CMC expertise and support to cross-functional project teams to ensure timely and successful project execution.
Qualifications:
- Advanced degree (Ph.D. preferred) in a relevant scientific discipline (e.g., Biochemistry, Molecular Biology, Chemical Engineering).
- Minimum of 15 years of experience in CMC roles within the biopharmaceutical industry, with at least 10 years in a leadership position.
- Proven track record of successfully leading CMC activities for biologic products through all phases of development and commercialization.
- In-depth knowledge of regulatory requirements for biologics, including experience with regulatory submissions and interactions with regulatory agencies.
- Strong leadership, communication, and interpersonal skills.
- Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.
What We Offer:
- Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies.
- Collaborative work environment with professional development and career growth opportunities.
- Competitive compensation package, including comprehensive benefits and stock options.
