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.
3-5 years of experience in a biotech/pharmaceutical company
*Previous pharmaceutical experience required*
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.
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.
Essential Job Functions:
Partner with development to support technology transfer by managing relationship with sending and receiving sites, authoring tech transfer documents, technical reports etc. 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 Life-cycle 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 mitigation with network wide implications and multiple functional areas
Results oriented with emphasis on strong planning and execution skills
Strong technical background and ability to work with subject matter experts across multiple functional areas
Effective communication skills with the ability to work effectively in cross functional teams.
Ability to effectively influence across levels, across functions and sites.
Ability to work in a complex, dynamic, global environment
Demonstrated ability to function in a collaborative/team oriented global technical team environment.
Apply for Technical Product Manager
Fill out the form below to submit your information for this oportunity. Please upload your resume as a doc, pdf, rtf or txt file. Your information will be processed as soon as possible.
Return to IT Job Search