Associate Director, Drug Product Development & Manufacturing

Mineralys Therapeutics

3d • $175,000 - $190,000 • Remote

About The Position

We are seeking a highly motivated and experienced individual to drive drug product development, technical operations, and commercial manufacturing readiness for small molecule pharmaceutical programs. This role will lead cross-functional efforts spanning formulation development, process development, technology transfer, validation, and supply chain coordination to support clinical and commercial objectives.

Requirements

• Advanced degree (PhD, MS, or BS) in Pharmaceutics, Chemistry, Chemical Engineering, or related field.
• 10+ years of experience in pharmaceutical drug product development.
• Strong expertise in solid oral dosage forms and pediatric formulations.
• Hands-on experience with DoE, statistical analysis tools (e.g., JMP, Minitab).
• Proven experience managing CDMOs and external partners.
• Strong 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 ability to work in fast-paced environments.

Nice To Haves

• Experience supporting products from early development through commercialization preferred.
• Analytical testing understanding is a plus.

Responsibilities

• 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 (Phase I–III) and commercial launch readiness.
• Define product specifications, control strategies, and ensure scalability and robustness.
• Apply Quality by Design (QbD), Design of Experiments (DoE), and statistical tools to optimize processes.
• Coordinate with supply chain and manufacturing to support production planning and scheduling.
• Identify and mitigate risks related to supply and manufacturing.
• Author and review CMC sections for regulatory submissions (IND, IMPD, NDA, MAA).
• Ensure compliance with FDA, EMA, ICH, and cGMP requirements.
• Support deviation investigations, CAPA, inspections, and audit readiness.
• Collaborate across functions including Analytical, Quality, Regulatory, and Supply Chain.

Benefits

• Position eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees