Quality Control Analyst

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 52,000 - 92,000; Full time

Benefits offered by this job

Student loan paydown program & tuition

Family care benefits

Relocation assistance

Inclusion, culture and well-being

Job summary

Regeneron Pharmaceuticals, Inc. in Saratoga Springs, NY is hiring multiple Quality Control Analysts to support our new fully automated drug substance manufacturing facility.

The role involves performing chemical, biological, and microbial analyses across raw materials, in-process materials, products, and stability samples to support quality programs. Initial location is Rensselaer, NY with permanent on-site work in Saratoga Springs; shifts include 1st shift Mon-Fri and rotating 12-hour

Qualifications

• Requires B.S in Life Sciences or related field.
• Associate Quality Control Analyst: 0-2 years of experience.
• Quality Control Analyst: 2+ years of experience.
• Senior Quality Control Analyst I: 4+ years of experience.

Responsibilities

• Gather data and documents test results.
• Review test results for compliance and report quality anomalies.
• Comply with all pertinent regulatory agency requirements.
• Participate in GMP training activities.
• Maintain laboratory supplies.
• Conduct testing and sampling on raw materials, in-process, product, stability, and research samples.
• Write and revise control test procedures and SOPs.
• Complete test records and reviews data.
• Calibrate or verify calibration of instruments/devices prior to use.
• Interact with outside customers or functional peer groups.
• Engage in exciting projects aligning to our scientific initiatives.
• Devise or develop new analytical methods and techniques.
• Assist in validation of methods.
• Partner with internal teams on establishing the transfer of methodology from R&D

Education

B.S in Life Sciences or related field

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're hiring multiple Quality Control (QC) Analysts to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. The QC Analyst performs a variety of chemical/biological/microbial analyses or sampling on raw materials, products, in-process materials, utilities, environmental monitoring, or stability samples in support of the company’s quality program.

When & where: Location: Initial: Rensselaer, New York, United States Permanent: Saratoga Springs, New York, United States Work model: Initial: full time, on-site 1st, Mon-Fri, 8am-4:30pm Permanent: full time, on-site, rotating 12-hour shifts, 7am-7:30pm , 3–4 days per week, includes 1 weekend day Transition: candidates must be able to work both schedules. The permanent shift start date will be communicated with reasonable advance notice and is subject to business needs.

What you'll do:

• Gather data and documents test results
• Review test results to ensure compliance with standards; reports any quality anomalies
• Comply with all pertinent regulatory agency requirements
• Participate in required GMP training activities
• Maintain laboratory supplies
• Conduct testing and sampling on raw materials, in-process, product, stability, and/or research samples
• Write and revise control test procedures and standard operating procedures (SOPs)
• Complete test records and reviews data
• Calibrate or verify calibration of instruments/devices prior to use
• Interact with outside customers or functional peer groups
• Engage in exciting projects aligning to our scientific initiatives
• Devise or develop new analytical methods and techniques
• Assist in validation of methods
• Partner with internal teams on establishing the transfer of methodology from R&D

The environment and physical rhythms of the role:

• Gowning: Full cleanroom attire (examples may include: laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

Let's find out if we're a fit:

• Requires B.S in Life Sciences or related field; or equivalent combination of education and experience
• Associate Quality Control Analyst: 0-2 years of experience
• Quality Control Analyst: 2+ years of experience
• Senior Quality Control Analyst I: 4+ years of experience
• Level will be determined based on experience
• Thrive today. Grow Tomorrow.

Benefits:

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)

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.

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, and family support benefits.

Salary Range (hourly) $24.76 - $44.42

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.