Director/Senior Director, CMC, Drug Substance

About the role

We are seeking a Director/Senior Director, CMC, Drug Substance to join our team. The role involves managing and overseeing the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for late-stage clinical trials through validation. You will be a key member of a highly collaborative internal CMC team, primarily managing API development programs and manufacturing campaigns (i.e. registration, validation), and managing contract development and manufacturing organization (CDMO) selection and technical transfer processes.

Responsibilities

• Manage and oversee the development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards.
• Evaluate, recommend, and manage qualified CDMOs for the manufacture of API for clinical trials, as well as for commercial use.
• Serving as the subject matter expert, participate in audits and inspections of API CDMOs in conjunction with Quality Assurance.
• Collaborate closely with the internal process chemistry team, manage API process technology transfer to the Company’s CDMOs, including process validation and the establishment and refinement of suitable specifications for APIs.
• Work closely with Supply Chain and CMC Drug Product colleagues to translate demand forecasts (both clinical and commercial) into API manufacturing plans.
• Author (in conjunction with Technical Writing) and/or act as a key reviewer of core CMC documents/modules and other forms of submissions and responses to FDA and other Competent Authorities providing strategic oversight and consistency for regulatory interactions, including, but not limited to, IND/NDA/MAA/IMPD filings and periodic updates thereto.
• Plan and manage API-related budget proposals and approved project budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports in accordance with the Company’s Human Resource policies and practices.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.

Qualifications

• PhD in Chemistry, Chemical Engineering or other relevant discipline with a minimum of 10 years of directly-related experience in a pharma or biotech environment.
• Candidates with a MSc and significant relevant experience may be considered as well.
• Demonstrated track record in successfully managing development-stage and/or commercial-stage API manufacturing activities conducted at CDMOs.
• Experience authoring/co-authoring key CMC sections in U.S. NDA and European MAA filings for small molecule APIs.
• Extensive knowledge of cGMP-related regulations, guidance documents, principles and best practices pertinent to APIs.
• Experience with CDMO selection, vendor management, contracting, issue resolution and management.
• Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel and experience in applying risk-based decision-making tools.
• Excellent oral and written communication and interpersonal skills as well as the ability to build credibility and trust inside and outside the Company.
• Excellent attention to detail and commitment to providing accurate, high-quality work.
• Good organizational skills and the ability to manage multiple competing priorities.
• Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.
• Be science- and data-driven while at the same time, creative and flexible in strategic thinking and problem solving.