Associate Director, Drug Product Development & Manufacturing

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone.  Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor.  Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”

Mineralys is a fully remote company.

Associate Director, Drug Product Development & Manufacturing

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.

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.

Travel

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

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. 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

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