Associate Director/Director, Drug Product

Apnimed is a rapidly growing pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea (OSA) could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program, AD109, targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Apnimed is committed to innovation, as well as state-of-the-art advancements in sleep medicine, which is leading to the development of a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Recognized by the Boston Business Journal as one of the Best Places to Work in both 2024 and 2025, we are continuing to grow and build the foundational operations that enable our employees and our mission to thrive. Summary: The Associate Director/Director, Drug Product reports to the Senior Director, Drug Product Development and Manufacturing and is responsible for working on the AD109 drug product process validation, manufacturing, and technical quality support at contract development and manufacturing organizations (CDMOs) to meet clinical and commercial demand. The successful candidate will also play a key role in partnering with Global Supply Chain and Analytical Development & Quality Control, managing drug product suppliers and supply agreements, and authoring technical content for regulatory filings. This is an exciting opportunity to help bring AD109 to patients and be at the forefront of a major paradigm shift in the treatment of sleep apnea from medical devices and surgery to a first in class pharmaceutical treatment. Key Job Duties include, but are not limited to: Oversee the drug product manufacturing process validation (PPQ) campaign at CDMOs Review and provide technical approval of batch records for PPQ lots and future clinical and commercial lots. Oversee post-approval drug product manufacturing in conjunction with Global Supply Chain (GSC), and ongoing stability programs in conjunction with Analytical Development and Quality Control (ADQC). Provide technical support for resolving manufacturing-related deviations, quality issues arising from clinical or commercial product complaints, temperature excursions, and similar events. Support drug product formulation and process development at CDMOs. Identify, select, engage, and oversee additional drug product suppliers as needed to support clinical and commercial demand. Support the development, review and execution of RFPs, Statements of Work, Master Service Agreements, and other manufacturing governance documents . Author and review CMC sections for global regulatory filings, updates, and inquiry responses. Adhere to applicable regulations, including FDA, EMA, ICH, and Apnimed policies. Qualifications: Bachelor's degree or equivalent in pharmaceutical sciences, chemical engineering, chemistry, or a related life science; advanced degree preferred. 8+ years of drug product development and/or manufacturing experience in the pharmaceutical industry (10+ years for the Director level). Experience overseeing drug product manufacturing and process validation (PPQ) at CDMOs for oral solid dose products. Working knowledge of direct compression formulation and film coating processes, including pan coating implementation and scale-up. Strong knowledge of cGMP, with experience reviewing and approving batch records and supporting investigations, complaints, and temperature excursions. Experience selecting, qualifying, and managing CDMOs and drug product suppliers, including support of supply agreements. Understanding of cGMP, ICH, FDA, and EMA guidelines Experience authoring CMC sections of regulatory filings and responding to agency questions (e.g., IND, NDA). Ability to manage simultaneous priorities and changing deadlines in a fast-pace environment. Excellent oral and written communication skills. Ability to plan, organize and prioritize work. Proven ability to work independently and be self-motivated. What Apnimed Offers: 401(k) with company match Generous time off for vacation Generous healthcare benefits Flexible working environment Motivated and experienced team Winner of 2024 Boston Business Journal Best Places to Work Location and Other Information: Apnimed is a publicly licensed company based in Cambridge, MA; we are generally virtual and specific location within the US is not critical. We are a small growing Company with an inclusive environment. Must be able to travel as necessary. Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment. Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea.