Associate Director - TSMS Dry External Manufacturing

Responsibilities

• Manage the activities of TS/MS and ENG personnel supporting the oversight of external manufacture of dry products.
• Balance coaching a technical and engineering staff, prioritization and staffing for routine production support activities, implementation of technical projects, technical transfers, commercialization, process optimizations and engineering activities oversight.
• Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation and engineering practices.
• Work cross-functionally within sites, network, commercialization teams, and multiple global contract manufacturers to deliver on technical /engineering objectives, specific product business plan, and quality objectives.

Key Objectives/Deliverables

• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Performance management and development of staff.
• Partner within TS/MS, ENG and across functional disciplines to influence and implement the technical agenda, site business plan objectives, functional objectives, and GMP Quality Plan objectives.
• Ensure appropriate technical and Engineering oversight and stewardship of oral solid dose form manufacturing and packaging including drug product intermediates (e.g. spray dried dispersions/amorphous solid dispersions).
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
• Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio.
• Ensure adequate oversight and technical excellence for investigations and complaints including CAPA and monitoring improvement.
• Ensure adequate oversight for technical projects/technical agenda to improve process control, capacity, yield, quality.
• Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
• Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.
• Escalate to Sr. Leaders in a timely fashion risks to supply, manufacturing issues major deviations, critical complaints or safety and cybersecurity issues.
• Lead implementation and execution of activities aligned with emerging need related to process improvement, control strategy or new regulation and ensure any emerging need is incorporated into the CMs technical agenda.

General

• Contribute to CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options.
• Contribute to Business Plan and Strategic Plan processes.
• Serve as cross-functional member on DryEM Lead Team.
• Ensure JPT objectives and priorities are delivered and issues escalated.
• Support financial planning and reporting for Dry EM.

Qualifications

• Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Biotechnology, Pharmacy, Engineering or another related field.
• 8+ years’ experience in Dry Products/Oral Solid Dose pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Engineering at a manufacturing site.
• Previous leadership/people management experience.