Associate Director TSMS

About the role

The Associate Director – Technical Services / Manufacturing Science (TSMS) – API is responsible for providing technical and people leadership across Active Pharmaceutical Ingredient (API) manufacturing processes supporting cGMP commercial and late-phase operations. This role oversees the full lifecycle of technical activities including technology transfer, process validation, manufacturing support, process optimization, and lifecycle management of API products.

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.
• Adequately oversee and ensure technical excellence for investigations and complaints. Ensure adequate oversight for technical projects to improve process control, capacity, yield, and quality.
• Adequately represent and engage within site and network governance meetings to influence technical agendas.
• 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.

Additional Preferences

• 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.

Basic 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.