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Lead Quality Control Micro Analyst (2nd shift)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
Feb 27, 2024

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

Regeneron is currently looking for a Lead Quality Control (QC) Microbiology Analyst with a Tuesday-Saturday, 2-10:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Microbiology Analysts perform microbiological assays, related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation. This position will be primarily responsible for performing routine and qualification environmental monitoring in aseptic fill and finish manufacturing areas, as well as gowning and aseptic qualifications, utilities sampling and testing, and raw materials, in process and finished product testing related to drug manufacturing. This position will have direct reports.

As a Lead QC Micro Analyst, a typical day might include the following:

  • Provides on-the-floor guidance and support to employees.
  • Ensures employees timesheets are completed on time.
  • Monitors employees training to ensure that all requirements are met, including OJT.
  • Maintain up to date training records for self and direct reports.
  • Perform minimally monthly performance feedback meetings with direct reports.
  • Escalates all performance issues to management and/or HR.
  • Performing gowning and aseptic qualifications for personnel
  • Environmental monitoring of controlled environments, personnel and clean utilities.
  • Microbiological testing and analysis (bioburden testing, endotoxin content testing, plate enumeration, growth promotion, etc.) on a variety of sample types, related to environmental monitoring, utility, raw materials, and in-process and final product materials.
  • Training of employees.
  • Peer review of data.
  • Technical writing assignments such as SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, change controls, etc.

This role might be for you if you:

  • Enjoy working in a fast-paced environment and you have the innate ability to balance multiple priorities and/or prioritize and execute them.
  • Can take on new and sometimes ambiguous challenges and learn quickly.
  • Are able to work in a team environment and demonstrate respectful behavior at all times to promote and encourage a learning environment.
  • Develop and drive scientific and/or business-related improvement ideas.
  • Have working knowledge of Microsoft Suite applications (Word, Excel, Powerpoint), Laboratory Information Management System (LIMS), Deviation Management Systems, and Learning Management Systems.

Shift Requirements: Physical

  • Ability to perform physical requirements for entirety of shift (up to 10 hours):

  • 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

Gowning and Environment

  • Full cleanroom attire (Examples may include: including 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 jewerly, make-up and nail adornments when wearing cleanroom attire

To be considered for the Lead QC Micro Analyst you must be willing and able to work Tuesday - Saturday, 2:00-10:30pm. You must have a BS/BA in Life Sciences, or related field and 1+ years of relevant experience; or an equivalent combination of education and experience.

Prior GMP experience in Microbiology related to drug substance (bulk) or drug product (fill/finish) manufacturing is preferred. Level is determined based on qualifications relevant to the role.

#LI-MB1

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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (hourly)

$26.73 - $48.08

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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