Associate Director, Drug Product Development – Manufacturing
MDWerks Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $175,000 - $190,000 per year
Job Level
About the role
- 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
Requirements
- 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
- 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
Benefits
- standard Company benefits including medical, dental, vision, time off and 401K
- participating in Mineralys incentive plans contingent on achievement of personal and company performance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
formulation developmentmanufacturing processesprocess validationprocess characterizationQuality by Design (QbD)Design of Experiments (DoE)statistical analysisregulatory submissionssolid oral dosage formspediatric formulations
Soft Skills
leadershipproject managementproblem-solvingcommunicationcollaboration