Associate Director, Process Development and Manufacturing

Oversees analytical and manufacturing functions, while translating the company’s strategic plans and objectives into tactical and functional plans to drive resource utilization.  Responsible for coordinating GMP manufacture of small molecule therapeutic compounds with contract manufacturing organizations (CMOs).  Ensures business processes and policies are implemented in compliance with corporate standards and operating principles, while complying with regulatory requirements to minimize risk to the organization.  Writes and reviews documents in support of regulatory Investigational New Drug (IND) and New Drug Application (NDA) filings.  Participates with executive management to align functions with company objectives.

Job Functions:

• Manages analytical research and development efforts.
• Reviews and approves analytical testing protocols and reports (internal and external).
• Works with CMOs, manufacturing/quality consultants, and Wellstat analytical, clinical, quality, legal and management groups to guide and coordinate the manufacture and use of active pharmaceutical ingredient (API) and drug product (DP) for clinical and commercial purposes.
• Coordinates with the clinical and quality groups to manage the supply and use of API and DP.
• Writes and reviews documents in support of IND and NDA filings and manufacturing-related documents, such as analytical assay methods, validation protocols and reports, stability protocols and reports, and regulatory submissions.
• Integrates efforts with corporate purposes and objectives through frequent interactions with executive management.
• Creates work plans for ongoing and new drug development opportunities.
• Identifies, evaluates and qualifies vendors and suppliers.
• Participates in vendor audits and FDA inspection preparation.

Skills/Experience Requirements:

• A minimum of 10 years’ management experience in the development of pharmaceutical and biopharmaceutical agents, with working familiarity of GLP and GMP requirements.
• Demonstrated subject matter expertise in small molecule drug development (Analysis Formulation or Manufacturing) with a history of regulatory agency filing support activities.
• Expert knowledge in scientific principles and concepts of pharmaceutical product development, with a strong data-analysis background and a results-oriented approach.
• Excellent working skills of Microsoft Office software and data graphing programs required.
• Project Management experience in supporting/leading drug development teams.
• Strong verbal and written communication skills.
• Writing the Chemistry, Manufacturing and Control (CMC) portion of agency submissions in support of INDs, NDAs, and annual reports.
• GMP assay development and operation.
• Coordinating and integrating efforts between regulatory affairs, CMOs and other external partners and executive management of the company.

Educational Requirements:

Ph.D. in Chemistry, Biochemistry or PharmD with 10+ years of experience, or a M.S. in Chemistry or Biochemistry with 15+ years of experience.

Other:

During the COVID-19 pandemic, it is expected that the successful candidate will work onsite in Rockville, MD at least three (3) days per week.  Thereafter, the onsite work schedule is yet to be determined.

Wellstat Therapeutics Corporation is an equal opportunity employer and offers an excellent salary and benefits package.