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.

• 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.

• Responsible for maintaining a safe work environment.
• Ability to influence and lead diverse groups.
• Influences complex regulatory, business, or technical issues within the site and function.
• Hands‑on experience with digitalization initiatives including MES implementation, data historian platforms (e.g., OSIsoft PI), digital execution platforms, or LIMS systems.
• Track record of leading or contributing to continuous improvement programs leveraging digital tools and data analytics.
• Technical leadership, administrative and organizational skills.
• Builds relationships with internal and external customers and partners.
• Proficiency in delivering highly complex tasks and/or tasks that are highly cross‑functional.
• Demonstrated Project Management skills and ability to coordinate complex projects.
• Strong analytical and quantitative problem‑solving skills.
• Ability to communicate and influence effectively across functional groups and stakeholders.
• Strategic thinking and ability to balance short‑term needs with long‑term business evolution.
• Enthusiasm for changes, team spirit and flexibility.

• Minimal travel (