Associate Director - TS/MS - Lebanon API

Role Summary

Associate Director – Technical Services/Manufacturing Science (TSMS) for Lebanon API site, responsible for managing TSMS personnel, coordinating cross-functional activities to support GMP manufacturing operations, and guiding technical projects and process optimizations during startup and ongoing operations.

Responsibilities

• 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.
• Complete formal Performance Management and development of staff. Provide coaching and direction to team members.
• Partner within TSMS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• 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.
• Ensure adequate oversight and technical excellence for investigations and complaints.
• Ensure adequate oversight for technical projects 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.

Qualifications

• Bachelor‚Äôs Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field.
• 5+ years of experience in TSMS in a pharmaceutical manufacturing environment.
• 2+ years of experience leading teams

Additional Preferences

• Ability to work with a team, make independent decisions, and influence diverse groups.
• Ability to instill teamwork within the department and demonstrate key interpersonal skills.
• Ability to provide innovative solutions to plant, divisional, and corporate issues and leverage ideas from other functional areas.
• Demonstrated Project Management skills and ability to coordinate complex projects

Education

• Not specified

Additional Requirements

• None specified