Project Specialist Quality Control

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 67,000 - 110,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension benefits

401(k) match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc in Rensselaer, NY is seeking a Project Specialist for the Quality Control Technical Resources team. You will manage validation and qualification activities and coordinate transfers to partner labs, while maintaining lifecycle management of QC assays.

The role offers exposure to multiple teams and growth in a fast-paced biotech environment. The position requires a BS/BA in Chemistry, Biochemistry, Biology or related field with 3+ years of relevant experience and GMP

Qualifications

• BS/BA in Chemistry, Biochemistry, Biology or related field with 3+ years of relevant experience.
• Experience with project management and GMP setting is required.

Responsibilities

• 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)

Skills

Project management

GMP experience

Quality control

Cross-functional collaboration

Documentation writing

Education

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

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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.

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.

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.

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. 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.

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

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