Regeneron is currently looking for a Project Specialist to join our Technology Transfer MSAT team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Project Specialist will provide project management support for the internal / external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and cell and gene therapies.
As a Project Specialist, a typical day might include 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.
- Reviews controlled document content updates (e.g., MRs, SOPs) to ensure harmonization across production suites.
- 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.
This role might be for you if:
- Enjoy working in a fast-paced environment.
- Are able to multi-task, prioritize and execute projects and communicate cross-functionally to business units.
- Can take on new and sometime ambitious challenges and learn quickly.
- Are able to write transfer project plans and reports.
- Possess effective time management skills, and the drive to meet deadlines.
- Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint) and MS Project.
- Understand, at a basic level, manufacturing processes for monoclonal antibodies/therapeutic proteins and cell and/or gene therapy products.
To be considered for the Project Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in a scientific discipline, chemistry or biology is preferred. For various levels you must have the following:
Project Specialist: 2+ years of relevant experience
Sr. Project Specialist: 5+ years of relevant experience
Level is determined based on qualifications relevant to the role.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)