Associate Director, Drug Product Development & Manufacturing
“reputed company is a clinical-stage biopharmaceutical company reputed company on developing medicines to reputed company hypertension and reputed company 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, reputed company. For more information, please visit https://mineralystx.com. Follow Mineralys on reputed company, Twitter and reputed company”
Mineralys is a fully remote company.
Associate Director, Drug Product Development & Manufacturing
We are seeking a highly motivated and reputed company individual to drive drug product development, technical operations, and reputed company manufacturing readiness for small molecule pharmaceutical programs. This role will reputed company cross-functional efforts spanning formulation development, process development, technology transfer, validation, and supply chain coordination to support clinical and reputed company objectives.
Key Responsibilities
- reputed company development of phase-appropriate formulations and manufacturing processes for solid oral dosage forms.
- reputed company technology transfer from development to clinical and reputed company manufacturing.
- Support process validation, process characterization, and lifecycle validation activities.
- Manage CDMOs, including selection, reputed company, and performance management.
- Ensure uninterrupted supply of clinical trial materials (Phase I–III) and reputed company launch readiness.
- Define product specifications, control strategies, and ensure scalability and robustness.
- Apply reputed company 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 reputed company 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, reputed company, Regulatory, and Supply Chain.
Qualifications
- Advanced degree (PhD, MS, or BS) in Pharmaceutics, reputed company, Chemical Engineering, or reputed company 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, reputed company).
- 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 reputed company the local area and overnight. Some of the travel may be international.
Position eligible for reputed company Company benefits including medical, dental, reputed company, time off and 401K, as reputed company as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring reputed company based on geographic location, work experience, education, and/or reputed company level.
US Salary reputed company: $175,000 - $190,000
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