[Hiring] Associate Director, Drug Product Development & Manufacturing @Mineralys Therapeutics

Role Description

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
• Supply chain coordination

Key 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.

Qualifications

• Advanced degree (PhD, MS, or BS) in Pharmaceutics, Chemistry, Chemical Engineering, or related field.
• 10+ years of experience in pharmaceutical drug product development.
• Experience supporting products from early development through commercialization preferred.
• Strong expertise in solid oral dosage forms and pediatric formulations. Analytical testing understanding is a plus.
• 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.

Requirements

• This position requires up to 30% travel. Frequently travel is outside the local area and overnight. Some of the travel may be international.

Benefits

• Standard Company benefits including medical, dental, vision, time off, and 401K.
• Participation in Mineralys incentive plans contingent on achievement of personal and company performance.
• Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
• US Salary Range: $175,000 - $190,000