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

Role Summary

Associate Director, Manufacturing Science and Technology (MS&T) supporting Process Development and Clinical Supply for Harmony Biosciences. Focus on late-stage development programs, tech transfer, scale-up, process validation, and regulatory submissions across solid oral dosage forms and other dosage forms.

Responsibilities

• Ensure seamless transfer of knowledge as programs progress to later development stages
• Lead tech transfer, scale-up and validation from development to clinical and commercial manufacturing for multiple dosage forms
• Oversee multiple contract organizations to assure 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 studies
• Collaborate cross-functionally with Manufacturing Development, Regulatory Affairs, Quality, Supply Chain, and Clinical teams
• Coordinate manufacturing of clinical drug product with Supply Chain and Clinical Supply for various trial timelines
• Serve as Process Development lead on cross-functional teams, providing SME for manufacturing processes
• Ensure CMOs meet business objectives and quality/compliance standards
• Author and review CMC regulatory submissions including process descriptions, validation strategies, and control strategies
• Maintain uncompromising quality and patient safety as core responsibilities
• Provide technical support transferring complex manufacturing processes to commercial manufacturing and between sites
• Support drug product manufacturing, packaging and testing as needed
• Interpret process and quality data to drive continuous improvement and robustness
• Provide technical support in manufacturing, packaging and testing of drug substances/products at pilot and commercial scales
• Travel to CMOs and internal/external sites for on-site activities, audits, investigations, and process verification

Qualifications

• Bachelor‚Äôs degree in pharmaceutical sciences, chemical engineering, or related field; Master‚Äôs or PhD preferred
• 8+ years in pharmaceutical development/manufacturing, process characterization, tech transfer, and process validation
• Extensive experience in solid oral dose manufacturing; exposure to other dosage forms beneficial
• Proven track record in technology transfer, clinical/commercial scale-up, and process validation
• Experience with CMOs including 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 abilities
• Preferred knowledge of pharmaceutical analytical instrumentation and methodologies
• Strong knowledge of cGMPs and quality principles
• Working knowledge of supply chain planning and operations
• Proficient in Microsoft Office; focus on MS Project and Excel

Education

• Bachelor‚Äôs degree required; Master‚Äôs or PhD preferred

Additional Requirements

• Global travel up to 25%; valid US passport required
• Ability to work in environments ranging from office to manufacturing; hearing protection may be required
• Occasional lifting of >20 pounds; close vision; manual dexterity for computers and devices