Manager, Technology Transfer - API Manufacturing - Eurofins CDMO Alphora, Inc.

Eurofins CDMO Alphora is looking for a Manager, Technology Transfer to support our cGMP manufacturing facilities.  The Manager, Technology Transfer is accountable to the Director of Operations and provides leadership and strategic oversight for the Technology Transfer department in alignment with the Manufacturing Business Unit objectives.  In addition to departmental oversight, the role is also responsible for the design, timely implementation, and the safe execution of chemical processes while adhering to current Good Manufacturing Practices (cGMP), Environmental Health and Safety (EHS) and Eurofins CDMO Alphora's practices.

This role is onsite.

KEY DUTIES AND RESPONSIBILITIES:

• Provide leadership to a team of 5-10 Process Specialists
• Manage the department activities including administrative, resourcing, planning, training, performance management, recruitment, and budgetary tasks.
• Support the production schedule while working closely with key stakeholders in the Manufacturing BU.
• Work collaboratively with key stakeholders across the organization to support the team with the:
  • Design of safe and scalable processes to be executed from gram scale to multi-kilo scale in Eurofins CDMO Alphora’s manufacturing facilities
  • Execution to timelines to meet milestones
  • Generation of Master Batch Records
  • Scheduling of batch meetings
  • Review of Executed Batch Records (EBRs) to support the release process
• Coordinate and oversee exception management to ensure compliance to deadlines.
• Manage and promote departmental compliance to meet CAPA, audit, and training commitments.
• Establish effective process workflows for Technology Transfer
• Establish and maintain departmental KPI’s to track performance
• Support the team/department in internal and external project meetings as required.
• Promote key Departmental and/or Company initiatives relating to continuous process improvements and the implementation of new technologies/equipment as required
• Provide leadership to bring the Operations and Technology Transfer Teams together to promote the training of personnel on key operations, safety, engineering controls, and process feedback to facilitate seamless process transfers.
• Support the production schedule while working closely with key stakeholders in the Manufacturing BU.
• Interact with clients as required.
• Interact with cGMP auditors or various agencies (e.g. FDA) as required.
• Participate in production/scheduling related meetings.
• Adhere to Eurofins CDMO Alphora’s Standard Operating Procedures (SOPs) and Environmental, Health and Safety Procedures (EHSPs).