Summary: Lead a team supporting intercompany and intracompany technology transfer of late stage and commercial biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins.
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
Lead the team responsible for the technology transfer project management or technology transfer technical support.
Lead external and internal organizational resources to achieve the requirements of the project plan.
Collaborate with all relevant departments to coordinate technology transfer activities.
Facilitate/lead/coordinate IOPS core team activities in support of technology transfer (document review and approval; knowledge transfer; process support) to ensure that all relevant information and materials are successfully communicated and applied during manufacturing in accordance with agreed upon timeline.
Track team activities and timelines to ensure that the deliverables within the project plan are met and are timely.
Prepare, distribute & present project status reports to project team members and management.
Manage and set priorities for specific projects/programs.
Provide project management and/or technical support pertaining to technology transfer.
Establish positive relationships with intracompany and intercompany (partners, CMOs) counterparts
Manage, prioritize, delegate assignments and review work of direct reports.
Provide leadership to generate options to resolve problems, prioritize, and decide appropriate courses of actions; implement decisions.
Oversee, participate and approve interviewing, hiring and training of departmental employees. Conduct performance evaluation for direct reports.
Define, document and establish controls for technology transfer and knowledge management; identify continuous improvement activities to improve performance.
Lead special projects as assigned.
Biopharmaceutical process development, manufacturing, or process engineering experience preferred.
Associate Manager requires BS/BA in a scientific discipline or engineering with 6 years of experience or equivalent combination of education and experience.
Manager requires BS/BA in a scientific discipline or engineering with 7 years of experience or equivalent combination of education and experience.
Senior Manager Associate requires BS/BA in a scientific discipline or engineering with 8 years of experience or equivalent combination of education and experience.
Level is determined based on qualifications relevant to the role.
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Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.