Associate Director, Drug Product Development & Manufacturing

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Drug Product Development & Manufacturing in United States.

This role offers the opportunity to lead drug product development and manufacturing operations for small molecule pharmaceutical programs in a fully remote and highly collaborative environment. You will oversee formulation development, process optimization, technology transfer, and clinical-to-commercial scale-up, ensuring readiness for both clinical trials and commercial launch. The position involves managing CDMOs, coordinating with cross-functional teams, and applying advanced analytical and statistical methods to drive robust, scalable processes. You will contribute to regulatory submissions, compliance activities, and quality management, while mitigating supply and manufacturing risks. This is a high-impact role where leadership, technical expertise, and strategic thinking combine to advance innovative therapies for patients. The role requires a hands-on approach and strong collaboration across R&D, Quality, Regulatory, and Supply Chain functions.

Accountabilities

• Lead development of phase-appropriate formulations and manufacturing processes for solid oral dosage forms
• Oversee technology transfer from development to clinical and commercial manufacturing
• Support process validation, process characterization, and lifecycle validation activities
• Manage CDMOs, including selection, oversight, and performance management
• Ensure uninterrupted supply of clinical trial materials and commercial launch readiness
• Define product specifications, control strategies, and ensure process scalability and robustness
• Apply Quality by Design (QbD), Design of Experiments (DoE), and statistical tools to optimize manufacturing processes
• Coordinate with supply chain and manufacturing teams to support production planning and scheduling
• Identify and mitigate risks related to supply and manufacturing
• Author and review CMC sections for regulatory submissions and support inspections and audits
• Ensure compliance with FDA, EMA, ICH, and cGMP requirements

Requirements

• Advanced degree (PhD, MS, or BS) in Pharmaceutics, Chemistry, Chemical Engineering, or related field
• 10+ years of experience in pharmaceutical drug product development, preferably supporting products from early development through commercialization
• Strong expertise in solid oral dosage forms and pediatric formulations; understanding of analytical testing a plus
• Hands-on experience with DoE and statistical analysis tools (e.g., JMP, Minitab)
• Proven experience managing CDMOs and external partners
• In-depth knowledge of cGMP, FDA, EMA, and ICH guidelines
• Experience contributing to regulatory filings and supporting inspections
• Demonstrated leadership, project management, and problem-solving skills
• Excellent communication and collaboration abilities in fast-paced environments
• Ability and willingness to travel up to 30%, including international travel

Benefits

Competitive salary range: $175,000–$190,000 USD

Standard benefits including medical, dental, vision, time off, and 401K

Participation in performance-based incentive plans

Fully remote work with flexible arrangements

Opportunity to work on high-impact pharmaceutical programs with cross-functional teams

Exposure to regulatory submissions, clinical trials, and commercial-scale manufacturing

Professional growth and development in a dynamic, innovative environment

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.