Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Support the technology transfer of late stage and commercial biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins to partners and CMOs.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Work directly with all relevant departments to coordinate technology transfer activities (assay transfer; document review and approval; knowledge transfer; process support)
- Manage project plans to ensure that the deliverables within the project plan are met and are on-time. Facilitate and track all multi-functional team project activities.
- Coordinate all IOPS communications pertaining to tech transfer to and from collaborative partners.
- Coordinate and track testing activities in QC in support of assay transfer.
- Coordinate and track testing activities in Regeneron (IOPS and Tarrytown) in support of comparability studies.
- Track document approval (e.g., deviations, records, change requests).
- Host training visits for partners; schedule meetings and training sessions with SMEs.
- Review technology transfer protocols and reports.
- Trend data generated as part of tech transfer
- Manage document exchange (during and post 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 & present project status reports to project team members and management.
- Travel may be required in support of tech transfer activities
Knowledge and Skills:
- Knowledge of large scale cell culture and bioseparation technologies. Understanding of analytical technologies related to pharmaceutical manufacturing of proteins.
- Knowledge of Technical transfer principles and general knowledge of budgeting.
- Demonstrated project management, organizational abilities, ability to handle multiple projects, duties and assignments.
- Good decision making, communication, presentation and troubleshooting skills
- Ability to work in a fast-paced environment, be organized and able to prioritize tasks to meet multiple deadlines.
- Solid knowledge of cGMP and other applicable regulations.
- Working knowledge of word processing, spreadsheet, and database management software.
Education and Experience:
- Requires BS/BA in a scientific discipline with 2+ years of related experience in a cGMP environment with significant emphasis on process technology transfer.
*Title level (Associate Project Specialist, Project Specialist, or Sr. Project Specialist) will be determined based on skills and experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
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