Associate Director TSMS

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.
• Hire, manage, mentor, and develop a team of scientists and technical staff, fostering a culture of excellence, accountability, and continuous learning.
• 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.
• Ensure adequate oversight and technical excellence for investigations and complaints. Ensure adequate oversight for technical projects to improve process control, capacity, yield, and 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.
• Champion the adoption and integration of data analytics platforms, statistical process control (SPC), and real-time monitoring tools to improve process performance and reduce variability.
• Partner with Digital/IT and Engineering functions to define and implement a site digitalization roadmap aligned with business and quality objectives.
• Drive digitalization initiatives including manufacturing execution systems (MES), digital execution, data historians, and advanced analytics dashboards to enable data-driven decision-making.

Qualifications

• B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences.
• 6+ years (B.S./M.S.) or 5+ years (Ph.D.) of relevant cGMP commercial API manufacturing experience in TSMS or associated disciplines such as Manufacturing, Quality Assurance, Quality Control, Engineering, or Regulatory Sciences.