Project Specialist Quality Control

Regeneron Pharmaceuticals; City of Rensselaer (NY); Vor Ort; USD 67.000 - 110.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals is seeking a Project Specialist to support the Quality Control Technical Resources Team in managing validation and qualification activities, transfers to partner sites, and lifecycle management of QC assays.

The role involves coordinating with internal and external teams, writing transfer protocols, SOPs, and driving timely project updates while maintaining GMP compliance in a fast-paced environment.

Qualifikationen

• BS/BA in Chemistry, Biochemistry, Biology or related field.
• 3+ years of relevant experience.
• Experience in a GMP setting.

Aufgaben

• Project manage validation and qualification activities within the QC TR Chemistry group.
• Coordinate with internal and external teams to coordinate project management activities.
• Write and revise assay transfer protocols to external partners and contract labs.
• Write and revise control test procedures and SOPs.
• Coordinate and participate in weekly project update meetings.
• Communicate to management any delay in validation/transfer timelines.

Kenntnisse

Project management

Microsoft Office

Ausbildung

BS/BA in Chemistry/Biochemistry/Biology or related field

Jobbeschreibung

We are currently looking to fill a Project Specialist on our Quality Control Technical Resources Team. This position will be supporting project management of validation and qualification activities, transfer to partner and contract sites, and life cycle management of assays utilized in Quality Control testing. Regeneron has successfully commercialized numerous products and in this fast-paced environment with a strong pipeline, QC Technical Resources Specialists have the opportunity to develop scientifically and also gain insight into other areas of the business.

When & Where:

• Monday-Friday, 8:00am-4:30pm
• Location: Rensselaer, New York, United States

Discover your role:

• Project manage validation and qualification activities within the QC TR Chemistry group
• Collaborate with internal and external teams to coordinate project management activities
• Write and revise assay transfer protocols to external partners and contract labs
• Write and revise control test procedures and SOPs
• Coordinate and participate in weekly project update meetings
• Communicate to management any delay in validation/transfer timelines
• Communicate method updates to partners and manage progress of updates
• Coordinate post-transfer investigations between contract sites and collaborative partners
• Raise discrepancies to management, as needed
• Multi-task, prioritize and execute projects independently
• Write and review transfer documents such as protocols and reports
• Communicate cross-functionally to business units
• Develop and drive scientific and/or business-related improvement ideas
• Possess effective time management skills, and the drive to meet deadlines
• Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

This role requires:

A BS/BA in Chemistry, Biochemistry, Biology or related field, with 3+ years of relevant experience.

Experience with project management and experience in a GMP setting.

Level is determined based on qualifications relevant to the role.

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.

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.

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, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$67,400.00 - $110,000.00