VP, Chemistry Manufacturing and Controls (CMC)

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

What You’ll Do: The Vice President of Chemistry, Manufacturing, and Controls (CMC) is responsible for leading and overseeing all aspects of the CMC function, ensuring the successful development, manufacturing, regulatory approval, and clinical supply of biopharmaceutical products. Reporting to the Chief Scientific Officer, this role involves strategic planning, cross-functional collaboration, and leadership to ensure the company’s products are developed efficiently, meet regulatory standards, and are commercially viable.

Responsibilities:

• Develop and implement the CMC strategy aligned with the company’s overall goals and objectives.
• Provide leadership and direction to the CMC team, fostering a culture of quality, innovation, collaboration, and continuous improvement.
• Oversee the development and optimization of small molecule drug substance and drug product manufacturing processes for biopharmaceutical products.
• Ensure the successful scale-up of processes from laboratory to clinical and commercial scale.
• Lead efforts in chemical process development, oral solid formulation development, analytical method development, process validation and drug supply.
• Ensure all CMC activities comply with regulatory requirements (e.g., FDA, EMA) and industry standards.
• Lead the preparation and submission of phase-appropriate CMC sections of regulatory filings, including INDs, and NDAs.
• Ensure the timely and cost-effective production of clinical and commercial supplies.
• Work with Quality Assurance to maintain quality system components to ensure product quality and compliance, including controlled documentation, change control, noncompliance/deviation management, CAPA, and training.
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other departments to ensure alignment and effective execution of CMC activities.
• Work with internal and external partners to drive CMC objectives forward and provide oversight and tracking of critical pipeline objectives
• Work with Quality Assurance and Regulatory Affairs to maintain inspection readiness.
• Participate in project teams and contribute to the overall product development strategy.
• Work with CMC functional department heads to develop and manage the CMC budget, ensuring clear oversight and efficient allocation of resources.
• Identify and address resource needs, including personnel, equipment, and facilities.
• Recruit, mentor, and develop CMC team members, fostering a high-performance culture.
• Provide guidance and support to ensure professional growth and development within the team.

Qualifications:

• Advanced degree (Ph.D., M.S., or equivalent) in Chemistry, Chemical Engineering, Biochemistry, or a related field.
• PhD or MS with 10+ years of CMC experience in the biotech/pharmaceutical industry, including work with contract manufacturers; advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
• Experience in early and late-stage drug substance development, formulation development, process development, clinical and commercial cGMP production including process validation experiments, pre-approval inspections, and commercial manufacturing
• Extensive experience managing US and International CMOs for the manufacture of drug substance and drug product
• Experience with authoring/reviewing regulatory documents (IND, CTA, NDA), specifically Module 3 sections of an IND/NDA, and FDA information requests, interfacing with regulatory agencies, and robust knowledge of relevant FDA and EMEA regulations and guidances
• Strong analytical, organizational, and time management skills with a track record of identifying and implementing novel solutions
• Demonstrated agility and ability to navigate and be successful in a fast-paced, dynamic work environment
• Proven hands-on leadership, project management and communication skills (written and verbal)
• Team player who is able to work and collaborate effectively with internal stakeholders as well as external contract organizations
• Proven ability to mentor and coach more junior team members and develop a strong scientific team

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.