Biologic Drug Product Manufacturing Process Expert

3 days ago

Hopewell Township, United States Ampcus Incorporated Full time
Job Title: Biologic Drug Product Manufacturing Process Expert

Ampcus Incorporated is a certified global provider of a broad range of Technology and Business consulting services. We are seeking a highly motivated Biologic Drug Product Manufacturing Process Expert to join our talented team.

Job Summary:

The Biologic Drug Product Manufacturing Process Expert will be responsible for leading the coordination of activities to transfer the drug product fill-finish process to the manufacturing site. The process consists of compounding, filling, and optical inspection. In this role, the incumbent will be charged with leading complex Technology Transfers and Process Performance Qualification (process validation) that drive reliability and sustainability of our products at external manufacturers.

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 their core team
  • Influence other functions/levels outside of own group and effectively leads cross functional and cross organizational teams 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
  • The incumbent should be an expert in biologic drug product manufacturing processes. Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable
  • Process validation knowledge for pharmaceutical ingredients or products is desirable
  • Domestic travel to manufacturing site required, up to 25% (Travel to Greenville, NC about 1x a month with short notice)
  • 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 assure ensure manufacturing site readiness, reliability and sustainability
  • As needed, provide SME input on complex investigations, root cause identification, product impact assessment and corrective and preventive actions implementation
  • Represent Pharmaceutical Innovative Medicine Supply Chain in interfacing with external manufacturing company
  • Manages international sample shipments, execution of shipping route verification studies per SOPs, supports investigations and CAPAs as technical expert in the Drug Product manufacturing process
  • Reviews and approves batch records, validation protocols, data, and reports
Requirements:
  • Proven track record in in at least three of these areas: project leadership, pharmaceutical process development, new product introduction, technology transfer, process validation, 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

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