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Senior Manager

2 months ago

Hopewell Township, United States Ampcus Incorporated Full time
Job Title: Senior Manager - Technology Transfer

Ampcus Incorporated is a leading provider of technology and business consulting services. We are seeking a highly motivated and experienced professional to join our team as a Senior Manager - Technology Transfer.

Job Summary:

The Senior Manager - Technology Transfer will be responsible for leading the coordination of activities to transfer the drug product fill-finish process to the manufacturing site. This includes compounding, filling, and optical inspection. The incumbent will provide technical insight and team leadership to effectively deliver qualification of equipment, methods, hold times, and manufacturing processes aligned with the supply chain network strategy.

Key Responsibilities:
  • Work independently to drive and execute projects of a complex nature where analysis of situations or data requires an in-depth evaluation of factors in multifunctional areas
  • Communicate efficiently with the core team and influence other functions/levels outside of own group to generally attain expected results for all parties
  • Travel to the manufacturer(s) as needed to provide on-site support or oversight, especially during production of qualification batches
  • Lead complex technology transfers with a focus on right-first-time execution and risk management
  • Perform as SME to identify technical areas for improvement, and supply chain improvement
  • Lead drug product Process Performance Qualification and preparation of regulatory reports
  • Support the internal and external teams to ensure manufacturing site readiness, reliability, and sustainability
Requirements:
  • Proven track record in at least three of the following areas: project leadership, pharmaceutical process development, new product introduction, technology transfer, process validation, and production support
  • Demonstrated technical competency and experience with biologic drug product
  • Demonstrated experience in managing technology transfers and/or Life Cycle Management projects and investigations
  • Partnering with R&D and JSC groups to improve the fit for plant and commercialization of new products into the supply chain
  • Personal and interpersonal skills/Leadership skills
  • Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites
  • Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level
  • Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver, and get results through the various matrix teams
  • Ability to influence and lead peers, superiors, and external partners, including interaction with senior management
  • Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly
  • Ability to manage complexity and change
  • Personal attitude and mindset
  • Motivated, self-starter able to work independently with demonstrated problem-solving skills
  • Drives for innovation and change to ensure competitiveness
  • Can-do mentality: takes initiative, creates a result-oriented working spirit in his/her team
  • Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals, or Bachelors + 8 years
Language:

Fluent in written and spoken English

Physical Requirements/Working Conditions:
  • Works in an international environment across different time zones
  • Travel: ~25% of time based on role and specific business goals
  • Virtual Network interactions, utilizing available infrastructure to communicate with Key Partners and Stakeholders