Senior Director, Drug Product Development and Manufacturing

Apnimed; Cambridge (MA); On-site; USD 210,000 - 320,000; Full time

Benefits offered by this job

401(k) with company match

Generous vacation time

Flexible working environment

Motivated and experienced team

Best Places to Work 2024/2025

Job summary

Apnimed is seeking a Senior Director of Drug Product Development and Manufacturing in Cambridge, MA. The role leads formulation development and manufacturing of small-molecule solids, coordinating with CDMOs to ensure reliable clinical and commercial supply while guiding regulatory filings.

You will drive lifecycle management, support IND/NDAs, and partner with Quality, Regulatory, Supply Chain, and Commercial to shape strategy for a first‑in‑class sleep apnea treatment.

Qualifications

• Bachelor or higher degree in a relevant science/engineering field.
• 10+ years in pharma/biotech with small-molecule development and manufacturing experience (MS or PhD preferred).
• Experience managing external CDMOs, tech transfers, clinical supply and commercial launch.

Responsibilities

• Lead drug product formulation development and manufacturing in a cGMP environment with external partners.
• Evaluate manufacturing changes for regulatory impact and provide strategic guidance.
• Support CMC across INDs, IMPDs, NDAs, and MAAs with cross-functional teams.
• Manage cross-functional CMC teams with QA, Regulatory, Supply Chain, and Clinical.
• Review manufacturing docs including development and campaign reports.

Skills

Leadership

External CDMO management

Strategic planning

Cross-functional collaboration

Communication

Problem solving

Independent work

Education

Degree in Pharmaceutical Sciences, Life Sciences, Engineering, or related

Tools

MS Word

PowerPoint

Excel

Outlook

Job description

Apnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., we are developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders.

Summary:

The Senior Director, Drug Product Development and Manufacturing reports to the Senior Vice President, Technical Operations and is responsible for all aspects of drug product formulation development and manufacturing of small molecule solid oral dosage forms in the company’s product portfolio. The successful candidate will manage external drug product development and manufacturing activities, ensure reliable clinical and commercial supply, and contribute to strategic planning within Technical Operations, serving as a recognized technical expert who partners cross‑functionally across Quality, Regulatory, Supply Chain, and Commercial. This is an exciting opportunity to drive development and commercialization 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:

• Manage drug product formulation development and manufacturing activities in a cGMP environment at external service providers (CDMOs)
• Evaluate proposed manufacturing changes for potential impact on ongoing and existing global regulatory filings and provide strategic technical guidance for optimal implementation
• Support CMC activities across the drug product portfolio, including authoring and reviewing CMC sections for global regulatory filings (INDs, IMPDs, NDAs, MAAs)
• Serve as an integral member of cross‑functional CMC teams, partnering with Quality Assurance, Regulatory, Supply Chain, and Clinical teams
• Review and approve manufacturing documentation including development reports, campaign reports, and other relevant documents
• Provide technical review of manufacturing batch records
• Oversee process development, technology transfer, process optimization, and lifecycle management activities
• Provide technical support for resolving manufacturing‑related deviations, implementing change controls, conducting investigations, and developing complaint responses
• Support development of RFPs, Statements of Work, Master Service Agreements, and other manufacturing governance documents
• Promote knowledge management, documentation best practices, continuous improvement, and operational excellence initiatives while representing Drug Product Manufacturing on internal and external cross‑functional teams
• Communicate CMC project status to key stakeholders cross‑functionally
• Adhere to applicable regulations, including FDA, EMA, ICH, and Apnimed policies

Education and Experience:

• Degree in Pharmaceutical Sciences, Life Sciences, Engineering, or a related discipline
• Minimum 10 years of pharmaceutical/biotech industry experience in small‑molecule drug product development and manufacturing (MS or PhD preferred)
• Extensive experience in cGMP oral solid dose manufacturing practices (e.g., spray drying, granulation, tableting, coating, encapsulation)
• Significant experience managing third‑party drug product CDMOs, including tech transfers, clinical supply production, registration batches, validation batches, and commercial launch and supply activities
• Proven experience managing drug product development teams and external partners
• Strong understanding of cGMP, ICH, FDA, and EMA guidelines
• Prior experience supporting IND and NDA filings and response to questions

Skills:

• Ability to plan for and manage simultaneous priorities and changing deadlines in a fast‑paced environment
• Excellent oral and written communication skills
• Proficiency in the use of MS Word, PowerPoint, Excel, Outlook, and other commonly used pharmaceutical industry software
• Excellent leadership, communication, and problem‑solving skills
• Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders.
• Excellent communication and presentation skills to efficiently relay information to staff, project teams, executive leadership, and other key stakeholders
• Proven ability to work independently and be self‑motivated

What Apnimed Offers:

• 401(k) with company match
• Generous time off for vacation
• Flexible working environment
• Motivated and experienced team
• Winner of 2024 and 2025 Boston Business Journal Best Places to Work

Location and Other Information:

• Apnimed is a publicly listed 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.