Project Manager - Technology Transfer

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 commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Leads internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support.

Level to be determined based on qualifications relevant to the role.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Lead 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.

• Create, maintain and execute project plans and timelines to ensure that the deliverables within the project plan are met and are on-time.

• Coordinate and lead IOPS communications pertaining to tech transfer of the applicable protein to and from collaborative partners, as applicable. Serve as a primary point of contact for project related issues.

• Generate and review documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, as appropriate).

• Prepare, distribute & present project status reports to project stakeholders, team members and management (both internal and collaborative partners, as applicable).

• Author transfer proposals.

• Lead and/or facilitate investigations associated with tech transfer activities.

• Lead growth of the organizational process assets (lessons learned depository, risk register, templates, etc.). Identify and implement new solutions to improve tracking, planning and collaboration; develop tools to improve efficiency.

• Proactively identify issues and provide general guidance to resolve project issues and develop solutions to meet project timelines, milestones and objectives.

• Host training visits for partners; schedule meetings and training sessions with SMEs.

• Track document approval (e.g., external protocols, records, change requests).

• 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.

• Provide post transfer support as part of life cycle management activities to ensure alignment across sites (activities may include new technology implementation, investigations).

• Contribute to regulatory filings, as required.

• Lead continuous improvement initiatives and special projects as assigned; manage and set priorities for specific projects.

• May supervise lower level team members and interns.

• Travel may be required in support of tech transfer activities.

Knowledge and Skills:

• Technical transfer knowledge beneficial

• Strong verbal communication skills required

• Ability to negotiate skillfully with both internal and external groups

• Strong business acumen, client-service and results orientation

• Highly effective in ambiguous environment

Education and Experience:

• Associate Project Manager requires BS/BA in a scientific discipline with 8 years of related experience in a cGMP environment, or MS with 7 years' experience, or a PhD with 2 years of experience; may substitute relevant experience for scientific degree; PMP certification or MBA and experience managing project partners and collaborators; biopharmaceutical process development, manufacturing or process engineering experience a plus.

• Project Manager requires BS/BA in a scientific discipline with 10 years of related experience in a cGMP environment, or MS with 8 years' experience, or a PhD with 5 years of experience; may substitute relevant experience for scientific degree; experience managing project partners and collaborators required; PMP certification and MBA; biopharmaceutical process development, manufacturing or process engineering experience a plus.

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 agencies: 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 will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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