Project Specialist - Technology Transfer

Location
Rensselaer, NY, United States
Posted
Feb 21, 2021
Ref
23392BR
Required Education
Bachelors Degree
Position Type
Full time
Summary: Provide project management support for the internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support

Essential Duties and Responsibilities include, but are not limited to, the following:
• Coordinate IOPS technology transfer core team activities to ensure that all relevant information, methods, and materials are successfully communicated and utilized 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 on-time.
• Take and distribute minutes from meetings.
• Host training visits for partners; schedule meetings and training sessions with SMEs.
• Track document approval (e.g., external protocols, records, change requests).
• Generate and review documentation supporting technology transfer (e.g., process descriptions, memos, protocols and reports, as appropriate).
• Coordinate and participate in investigations associated with tech transfer activities
• Manage document exchange during transfer.
• Review controlled document content updates (e.g., MRs, SOPs) and make a recommendation to partners/CMOs if these changes are needed to be made in their facility as well.
• Prepare, distribute and present project status reports to project team members and management.
• Coordinate and track testing activities in Regeneron (IOPS and Tarrytown) in support of tech transfer.
• Represent MSAT at various site-wide cross functional meetings.
• Support growth of the organizational process assets (lessons learned depository, risk register, templates, etc.)
• Travel may be required in support of tech transfer activities.
• Participate in continuous improvement initiatives and special projects as assigned.

Education and Experience:
• Title level (Associate Project Specialist, Project Specialist, or Senior Project Specialist) will be determined based on skills and experience.
o Associate Project Specialist requires BS/BA in a scientific discipline
o Project Specialist requires BS/BA in a scientific discipline with 2 years of related experience in a cGMP environment, or MS with 1 year experience; CAPM or PMP certification; biopharmaceutical process development, manufacturing or process engineering experience a plus
o Senior Project Specialist requires BS/BA in a scientific discipline with 5 years of related experience in a cGMP environment, or MS with 4 year experience or a PhD (entry level); MBA and PMP certification; biopharmaceutical process development, manufacturing or process engineering experience a plus

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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.