Associate Director, Manufacturing Science and Technology (MS&T)

Role Summary

Associate Director, Manufacturing Science and Technology (MS&T) responsible for technical and operational oversight of late-stage development programs, overseeing multiple drug product CDMOs, and coordinating IMP manufacturing to support clinical programs. Focus on technology transfer, scale-up, process validation, and regulatory submissions for solid oral dosage forms and other dosage forms as applicable.

Responsibilities

• Ensure seamless transfer of knowledge from Manufacturing Development to later development stages
• Lead tech transfer, scale-up, and validation from development to clinical and commercial manufacturing for multiple dosage forms (e.g., tablets, solutions, semi-solids)
• Oversee multiple Contract Organizations (COs) within Harmony’s global supply chain to ensure timely supply of clinical and commercial drug product inventories
• Design, execute, and analyze process validation studies and clinical supply campaigns
• Manage production and packaging of clinical drug and placebo across multiple clinical studies
• Collaborate with Manufacturing Development, Regulatory Affairs, Quality, Supply Chain, and Clinical teams to ensure end-to-end process support
• Coordinate manufacturing of clinical drug product with Supply Chain and Clinical Supply to meet trial timelines
• Serve as Process Development lead on cross-functional teams, providing SME for manufacturing processes and troubleshooting
• Ensure COs meet business objectives and quality/compliance standards
• Author and review CMC regulatory submissions (INDs, NDAs, IMPDs) including process descriptions, validation strategies, and control strategies
• Drive high quality and patient safety as core responsibilities
• Provide technical transfer support for complex manufacturing processes between development and commercial manufacturing and between sites
• Provide technical support for drug product manufacturing, packaging, and testing
• Interpret process and quality data to support continuous improvement and robustness
• Support manufacturing, packaging, and testing of drug substances and drug products at pilot and commercial scales
• Travel to CMOs and sites to support on-site activities, audits, investigations, and process verification

Qualifications

• Bachelor’s degree in pharmaceutical Sciences, Chemical Engineering, or related field; Master’s or PhD preferred
• 8+ years in pharmaceutical development and manufacturing, process characterization, tech transfer, and process validation
• Strong experience in solid oral dose manufacturing; exposure to other dosage forms is required
• Proven track record in technology transfer, scale-up, and process validation
• Experience managing CMOs with remote and on-site oversight
• Understanding of ICH, FDA, and USP guidelines and application to development stage
• Technical proficiency, creativity, collaboration, and independent problem-solving
• Knowledge of pharmaceutical analytical instrumentation is preferred
• Deep knowledge of Pharmaceutical Development and Manufacturing principles and current cGMPs
• Working knowledge of supply chain planning and operations
• Proficient in Microsoft Office Suite; MS Project and Excel familiarity

Education

• Bachelor’s degree required in pharmaceutical Sciences, Chemical Engineering, or related field; Master’s or PhD preferred

Additional Requirements

• Global travel up to 25%; valid US passport required
• Ability to work in environments with varying noise levels; hearing protection as needed
• Ability to lift and move up to 20 pounds occasionally
• Close vision and manual dexterity for computer and device usage
• Ability to sit for prolonged periods