Job Details

  • Title: Product Technical Manager
  • Code: RCI-15706
  • Location: Gaithersburg Maryland (MD) 20878
  • Posted Date: 10/16/2020
  • Duration: 6 Months
Talk to our Recruiter

  Job Description

The Product Technical Manager focuses on global end-to-end technical support of biologics products. The selected individual will provide in-depth technical oversight and tactical technical leadership for the assigned products throughout the commercial lifecycle. The role provides an opportunity to work across sites and functional areas and develop experience working with a diverse, global, cross-functional team to ensure product supply to patients.

  • Partner with development to support technology transfer by managing relationship with sending and receiving sites, authoring tech transfer documents, technical reports and supporting facility fit assessments and performing batch record reviews
  • Provide input on process development and manufacturing strategies
  • Support validation activities such as authoring validation protocols, supporting deviations during validation
  • Manage Lifecycle and Post Approval Changes by working with the Operations and development functions
  • Co-ordinate and drive to closure: major investigations at commercial CMOs and issues/risk mitigations with network wide implications and multiple functional areas
Position Qualifications:
  • 3-5 years of experience in a biotech/pharmaceutical company
  • Degree in Engineering or Biological Sciences or; minimum of: 5-7 years with a BS; 3-5 years with MS; or 1-3 years with a PhD
  • Experience with technology transfer and understanding of major unit operations in biotech manufacturing
  • Technical experience in biologics manufacturing (greater than 3 years direct experience with biologics manufacturing)
  • Prior experience in leading global, cross-functional technical projects or teams is highly desirable
  • Broad based experience of Operations including Manufacturing Science and Technology (MS&T), Manufacturing Operations, Supply Chain, Quality Assurance, or Quality Control
  • Excellent communication skills demonstrated with the ability to work effectively in cross functional teams and effectively influence team members. Establish effective relationships with stakeholders
  • Strong technical writer with knowledge of GMP documentation and Quality systems and processes
  • Ability to work in a complex, dynamic, global environment and willingness to travel when necessary
  • Innovative problem-solving skills
  • Statistical analysis experience is desirable