Project Manager-Technology Transfer

Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: November 24, 2022

Job Description:

We are currently looking to fill a Project Manager of Technology Transfer with a 1st shift, Monday-Friday, 8:00am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The role is responsible for leading internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and/or leads cross-functional specialized initiatives such as raw material readiness and raw material technical management in support of technology transfers.Essential Duties and Responsibilities include, but are not limited to, the following:

• Leads IOPS technology transfer core team activities to ensure that all relevant information, methods, and materials are successfully communicated and used during manufacturing in accordance with agreed upon timeline
• Leads specialized initiatives such as raw material readiness, supports and tracks new raw material qualification, aids in identifying alternate raw materials and technical implementation during technology transfers. Additional post transfer support may be required.
• Builds, maintains and implements project plans and timelines to ensure that the results within the project plan are met and are on-time.
• Coordinates and leads IOPS communications pertaining to tech transfer of the applicable protein to and from collaborative partners, as applicable.
• Serves as a primary point of contact for project related issues.
• Generates and reviews documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, raw material gap analysis, as appropriate).
• Prepares, distributes and presents project status reports to project partners, team members and management (both internal and collaborative partners, as applicable).
• Authors transfer proposals (external collaborations).
• Leads and/or facilitates investigations associated with tech transfer activities.
• Leads growth of the organizational process assets (lessons learned repository, risk register, templates, etc.).
• Identifies and implements new solutions to improve tracking, planning and collaboration; develops tools to improve efficiency.
• Proactively identifies issues and provides general guidance to resolve project issues and develop solutions to meet project timelines, milestones and objectives.
• Hosts on-site visits for partners; schedules meetings and training sessions with SMEs.
• Tracks document approval (e.g., external protocols, records, change requests).
• Manages document exchange during transfer.
• Contributes to and reviews regulatory filings, as required.
• Leads continuous improvement initiatives and manages and sets priorities for specific projects.
• May supervise junior level team members and interns.
• Travel and/or virtual support may be required in support of tech transfer activities.Education and Experience:
  • Associate Project Manager: Requires BS/BA in a scientific field and 8 years of related experience in a cGMP environment or equivalent combination of education and experience. Experience managing project partners and collaborators a plus. PMP certification a plus.
  • Project Manager: Requires BS/BA in a scientific discipline and 10 years of related experience in a cGMP environment, including experience managing project partners and collaborators, or equivalent combination of education and experience. PMP certification a plus.
  • Senior Project Manager: Requires PMP certification, BS/BA in a scientific discipline and 12 years of related experience in a cGMP environment, including experience managing project partners and collaborators, or equivalent combination of education and experience.
  • MBA a plus.
  • 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 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) $85,800.00 - $180,500.00

Keywords: Regeneron Pharmaceuticals, Inc., Troy , Project Manager-Technology Transfer, Executive , Troy, New York