Director Manufacturing Science and Technology Operations (MST)

Overview

Director - Technical Operations (MS&T): provide scientific leadership for the CDMO drug-product technical operations team covering manufacturing and packaging. The Middletown facility will produce oral solid dosage and sterile products. Responsible for setting transfer strategy, ensuring regulatory compliance, delivering reliable processes, and driving continuous improvement across people, processes, and technology. Drives GMP compliance, regulatory standards (FDA, EMA, ICH), and company policies.

Responsibilities

• New Product Introduction and Co-line Evaluation
  • Manage the process of new product introduction and co-line evaluation.
  • Guide department employees in reviewing and assessing the new product introduction information provided by the R&D department. For complex cases, organize communication and coordination with key personnel from relevant departments to make decisions.
  • Guide department employees in drafting co-line evaluation reports. For complex cases, organize internal discussions within STA to make decisions and communicate co-line strategies with customers.
• Technology Transfer (Clinical Projects)
  • Manage the technology transfer process of clinical projects from R&D to production.
  • Upon receiving clinical project production requirements, allocate TO support personnel based on the project's characteristics and department resources.
  • Guide department employees in drafting batch production records based on the process research data provided by the R&D department.
  • Regularly summarize and analyze the execution status of clinical projects (focused on quality and efficiency indicators) and communicate with the R&D management team.
• Technology Transfer (PPQ Projects)
  • Manage the technology transfer process of PPQ projects from R&D to production.
  • Lead and implement PPQ phase technology transfer projects, including transfer strategies, scheduling, document drafting/approval, problem-solving, and coordination.
  • Continuously monitor PPQ project progress and regularly report to production management.
  • Summarize PPQ execution status and organize joint review meetings with R&D management.
• Cleaning Verification and Cleaning Validation
  • Manage cleaning verification and cleaning validation processes.
  • Guide daily cleaning verification tasks, including drafting protocols and reports, sampling, and communication with Production/QC/QA.
  • Lead and implement cleaning validation work, including strategy development, protocol/report drafting, daily monitoring, and annual reviews.
  • Track execution status and report to production management.
• Commercial Project Support
  • Manage processes of continuous process verification and annual product quality review.
  • Guide collection/analysis of process data and drafting of continuous process verification reports.
  • Lead drafting/approval of annual product quality review reports.
  • Provide technical support for routine production, including drafting/evaluating changes, investigating deviations, and improving processes; offer technical guidance for complex issues in commercial production.
• Audit, Registration, and Regulatory Support
  • Organize customer and official audits within department responsibility, including pre-audit prep, responding during audits, and post-audit corrective actions.
  • Organize product registration support, including drafting/reviewing registration documents, responding to supplementary requests, and conducting supplementary study or validation.
  • Monitor regulations/guidelines relevant to the department and implement updates to internal processes as necessary.

Qualifications

• Required Qualifications:
  • BS/MS in Pharmacy or a chemistry-related major; familiar with pharmaceutical production, including manufacturing and cleaning processes; proficient in lean production management. (advanced degree preferred)
  • 10+ years of relevant experience in pharmaceutical production technology.
• Knowledge / Skills / Abilities:
  • Strong hands-on leadership style
  • Proficient in oral and written communication
  • Ability to read, write, and speak English
  • Proficiency in Microsoft Office (Excel, Word, Outlook)
  • Basic knowledge of statistics and its practical application in pharmaceutical production
  • Willingness to travel up to 20% (domestic and international)
  • Strong knowledge of regulatory requirements (FDA, EMA, ISO)
  • Excellent problem-solving and critical-thinking skills
  • Strong leadership, communication, and project management skills

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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