Associate Project Manager- Process Sciences

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 100,000 - 140,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Project Manager for the Process Sciences team in Rensselaer, NY.

You will manage bulk technology transfer projects across early and late phase programs and coordinate external transfers to CMOs and alliance partners. The role requires strong biopharmaceutical process knowledge, cross-functional leadership, and a proven track record in regulated manufacturing to ensure timely, compliant transfers and continuous improvements in TTMP and

Qualifications

• Bachelor's degree in science or engineering or related field.
• 8 years of proven experience in a regulated manufacturing environment.

Responsibilities

• Lead and manage internal and external transfers to ensure first-time GMP production success.
• Support transfers and efficiency projects (TTMP, TTM-R) with phase-appropriate goals.
• Lead cross-functional teams and manage results across projects and departments.
• Develop and maintain processes to address recurring issues and ensure timely completion of key quality tests.
• Provide liaison between Process Sciences and other departments; communicate status and risks.
• Travel to Regeneron locations and supplier/partner sites as needed to gather information.

Skills

Project management

Cross-functional teams

GMP knowledge

Process transfer

Education

Bachelors in science or engineering

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

We are seeking an Associate Project Manager to join our Process Sciences team. This individual will be responsible for bulk technology transfer project management across early and late phase programs within manufacturing (IOPS) and to external transfers to CMOs and alliance partners.

Location & Shift

• Location: Rensselaer, NY
• Shift: Monday- Friday- 8-4:30pm
• Travel: 5% domestic, sometimes international

Responsibilities

• This person will use their technical background and strong biopharmaceutical process knowledge to efficiently lead and manage internal and external transfers to ensure success first time for GMP production.
• This role will support transfers and is expected to participate and contribute to efficiency projects including updating TTMP, TTM-R and other PM responsibilities to reflect phase appropriate results.
• Leads cross functional teams and manages the results for the assigned projects, which may vary widely but are generally focused on technical activities and department operations
• Drives projects to completion on time and within regulatory guidelines.
• Develops and maintains a technical understanding of all departmental operations
• Develops tools and mechanisms for supervising department operations (e.g., training, budgets), communicates clearly about department status and proactively works to anticipate and prevent problems
• Proactively identifies emerging Process Sciences issues and provides guidance or assistance to resolve as needed
• Develops structured processes to address recurring problems or issues (e.g., flow of samples for testing to other departments, management of report-writing timelines), coordinates implementation
• Responsible for critical recurring tasks related to manufacturing processes such as scheduling of key quality tests, allocating of lots of key raw materials
• Provides oversight, organization, and accountability for critical tasks
• Provides administrative, organizational and mediation services for high-priority or emergency events as they arise - schedules meetings, takes meeting notes, communicates findings/action items/plans and ensures that actions are performed
• Acts as a first point-of-contact for department members at all levels who encounter difficult-to-solve problems and works to prevent or minimize risk/issues
• Acts as an impartial liaison between Process Sciences and other departments or groups - entertains complaints, concerns, and requests from external groups and determines how to best respond
• Responsible for maintaining open lines of communication and a positive working relationship with other departments
• Travels to other Regeneron locations and to supplier or partner sites and collects or disseminates information as needed and builds personal relationships while on site
• Other duties as assigned by manager

Qualifications

• Bachelors in science or engineering or related field and 8 years of proven experience
• Experience within a regulated manufacturing environment

Preferred Qualifications

• Experience within pharmaceutical or biotechnology industries
• Understanding of pharmaceutical drug substance manufacturing for biologics (monoclonal antibodies/therapeutic proteins)
• Project management over technology transfers within GMP production

Diversity & Inclusion Statement

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Salary & Benefits

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical,