Associate Project Manager - Technology Transfer
We are currently looking to fill a Project Manager - Technology Transfer. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Project Managers lead internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and/or lead cross-functional specialized initiatives such as raw material readiness and raw material technical management in support of technology transfers.
As a Project Manager - Technology Transfer, a typical day might include the following:
• Leading 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.
• Leading specialized initiatives such as raw material readiness, supporting and tracking new raw material qualification, assisting in identifying alternate raw materials and technical implementation during technology transfers. Additional post transfer support may be required.
• Crafting, maintaining and executing project plans and timelines to ensure that the deliverables within the project plan are met and are timely.
• Coordinating and leading IOPS communications pertaining to tech transfer of the applicable protein to and from collaborative partners, as applicable.
• Serving as a point of contact for project related issues.
• Generating and reviewing documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, raw material gap analysis, as appropriate).
• Preparing, distributing and communicating project status reports to project partners, team members and management both internal and collaborative partners.
• Authoring transfer proposals (external collaborations).
• Leading and/or facilitating investigations associated with tech transfer activities.
• Leading growth of the organizational process assets (lessons learned repository, risk register, templates, etc.).
• Identifying and implementing new solutions to improve tracking, planning and collaboration; develops tools to improve efficiency.
• Proactively identifying issues and providing general mentorship to resolve project issues and develop solutions to meet project timelines, landmarks and objectives.
• Hosting on-site visits for partners; schedules meetings and training sessions with SMEs.
• Tracking document approval (e.g., external protocols, records, change requests).
• Managing document exchange during transfer.
• Contributing to and reviews regulatory filings, as required.
• Leading continuous improvement initiatives and manage and set 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.
This role might be for you if you:
• Are familiar with antibody manufacturing processes and associated raw materials to assist in tracking new material qualification, identifying alternate raw materials and analyzing raw material gaps across sites as part of technology transfer projects.
• Seek to lead continuous improvements and system implementations to streamline tech transfer work and improve efficiencies.
• Can form strategic partnerships with technical and operational colleagues
• Are driven to assist in organization of work associated with tech transfers and onboarding of new raw materials / alternate raw material management.
• Have experience leading cross-functional teams towards a desired goal / outcome.
• Possess excellent time management, organizational and interpersonal skills.
• Thrive in dynamic environments and can translate ambiguity into actionable steps.
To be considered for the Project Manager - Technology Transfer you must have the following; Associate Project Manager, requires BS/BA in a scientific discipline 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 as is PMP certification. 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 and 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. Biopharmaceutical process development, manufacturing or process engineering experience and/or MBA is a plus. Level is determined based on qualifications relevant to the role Experience managing project partners and collaborators 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.