The Associate Director, Manufacturing will be responsible for the formulation, development, manufacture, and primary packaging of solid oral Drug Product (DP) at the established Contract Manufacturing Organization (CMO) sites. This role will also be responsible for process development, technical process studies, deviations and troubleshooting, tech transfer, and process validation activities for DP. Ability to lead and support writing and reviewing of key CMC sections of regulatory dossiers are also required for this position.
Major Duties/Responsibilities
* Lead the operational activities at the DP CMO, overseeing scheduling, manufacturing, and testing of DP.
* Serve as DP expert representative on multidisciplinary CMC teams.
* Review and approve master and executed batch records, change controls, and deviations to ensure GMP compliance and operational success.
* Apply fundamental chemical engineering and industrial principles to help optimize the process.
* Manage meetings with CMO, set agenda topics, generate meeting minutes, maintain timelines, and follow up on action items, internally and externally.
* Assist in review of specifications for DP; define and track manufacturing critical process parameters.
* In collaboration with colleagues in Quality, Regulatory Affairs, Project management and analytical groups manage and lead the CMO operations to achieve goals for on-time manufacturing.
* Support partners with CMC-related regulatory submission needs, release testing and reference material requirements, and other items as needed.
* Manage internal meetings, serve as subject matter expert for DP processes, and work closely with QA for timely commercial batch release.
* The candidate will communicate across the organization to ensure key stakeholders are aware of project status, potential risks and their required action plans.
* Generate, review, and/or contribute to technical reports for stability, continuous process verification (CPV), and annual product review (APR).
* Ability to manage stability and CPV programs and associated internal/external meetings for DP is a plus.
* Ability to provide QC support of data for release and stability of DS and DP is a plus.
Skills & Abilities
* Excellent interpersonal and communication, presentation skills
* Excellent organizational and project management skills, work well under pressure.
* Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships.
Physical Demands
* Ability to remain seated for long periods of time while working on computer or referring to documents.
Must have manual dexterity to operate computer keyboard and standard office equipment.
Positions: Standing, walking, sitting, stooping
Travel may be required (5-20%)
Education
Minimum of BS or MS degree in chemical engineering, chemistry, biochemistry or biology.
Experience
- Master's degree and 4-7 years of related experience - or- Bachelor's degree and 6-9 years of direct experience in pharmaceutical, small molecule drug development/manufacturing in GMP environment.
- Solid oral dosage form DP development/manufacturing experience.
- Direct experience with stability and/or continuous process verification (CPV) programs is a plus.
- Knowledge of small molecule analytical testing methods and impact on product quality specifications is a plus
- Knowledge of Business process, project management and operational excellence experience.
Special Training
- Think strategically to assess and improve processes to meet business needs globally.
* Ability to diagnose complex issues; develop and implement solutions by collaborating with other teams.
* Ability to support teams and be able to influence internal and external stakeholders.
