Associate Director/Director, CMC

Our client is a growing biotech that specializes in ADCs.

Job Summary:

We are seeking an experienced and dynamic Associate Director of CMC to lead and manage the Chemistry, Manufacturing, and Controls (CMC) activities for the development of biologic therapeutics, specifically focusing on Antibody-Drug Conjugates (ADCs), monoclonal antibodies (mAbs), and bispecific antibodies. This individual will work cross-functionally with various departments, including R&D, Regulatory Affairs, Quality, and Manufacturing, to ensure the successful development and commercialization of our biologic products. The ideal candidate will bring strong leadership, technical expertise, and a deep understanding of biologic drug development processes.

Key Responsibilities:

• Leadership and Strategy:

  • Lead and manage CMC activities for ADCs, mAbs, and bispecifics, from preclinical through clinical development and commercialization.

  • Develop and execute CMC strategies for biologics, ensuring alignment with regulatory requirements, development timelines, and business objectives.

  • Provide strategic input on CMC aspects during drug development programs and ensure seamless coordination with internal and external stakeholders.

• CMC Development & Manufacturing Oversight:

  • Oversee the development, characterization, and manufacturing of ADCs, mAbs, and bispecific antibodies at contract manufacturing organizations (CMOs) or internal facilities.

  • Ensure the successful transfer of processes from preclinical to clinical stages and manage scale-up activities.

  • Provide oversight of process development, optimization, and validation to ensure robust, scalable manufacturing processes.

• Regulatory & Compliance:

  • Lead the preparation and review of CMC sections for regulatory filings (INDs, CTAs, BLAs, etc.) to ensure compliance with FDA, EMA, and other global health authority requirements.

  • Interact with regulatory agencies as needed to resolve CMC-related queries or issues.

  • Ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and other relevant regulatory guidelines.

• Cross-functional Collaboration:

  • Collaborate with R&D, Quality Assurance, and Regulatory Affairs to ensure smooth progress from early-stage discovery through clinical trials and commercialization.

  • Work closely with project teams to ensure alignment and resolution of CMC-related issues throughout the development cycle.

  • Provide CMC expertise to clinical teams to support study designs, timelines, and data generation.

• Vendor Management & Contracting:

  • Manage relationships with CMOs and other external partners for development, manufacturing, and testing activities.

  • Lead technical and commercial discussions with external partners, including negotiating contracts and service agreements.

  • Ensure effective oversight and management of CMO activities, ensuring timely delivery and quality of products and services.

• Team Development and Mentorship:

  • Manage and mentor junior members of the CMC team, providing guidance, training, and support to foster their development.

  • Ensure the team is equipped with the skills, knowledge, and tools required to succeed in their roles.

Qualifications:

• Education:

  • Advanced degree (PhD, MS, or equivalent) in Life Sciences, Chemistry, Biotechnology, or related field.

• Experience:

  • Minimum of 8 years of experience in CMC development, with a strong focus on biologics, including ADCs, mAbs, and bispecific antibodies.

  • Demonstrated expertise in the development, manufacturing, and regulatory aspects of biologics.

  • Experience in managing cross-functional teams and leading complex development programs.

  • Strong track record of successful regulatory filings (e.g., IND, BLA).

  • Knowledge of GMP, GLP, and ICH guidelines, as well as experience with global regulatory requirements.

• Skills and Competencies:

  • Strong technical expertise in the development and manufacturing of ADCs, mAbs, and bispecific antibodies.

  • Proven leadership abilities, with experience managing teams and leading projects.

  • Excellent communication and interpersonal skills, with the ability to work collaboratively with internal and external stakeholders.

  • Strong project management skills, including the ability to manage timelines, resources, and budgets effectively.

  • Analytical thinking and problem-solving skills, with the ability to anticipate challenges and provide solutions.

  • Ability to thrive in a fast-paced and dynamic environment.

Preferred Qualifications:

• Experience in cell line development, process development, analytical development, and/or formulation development for biologics.

• Experience with biosimilar or gene therapy products.

• Familiarity with the latest trends and innovations in biologic drug development.