Lead QC Micro Analyst

3 weeks ago

Rensselaer, United States Regeneron Pharmaceuticals, Inc. Full time

Regeneron is currently looking for a Lead Quality Control (QC) Microbiology Analyst with a Wednesday-Saturday, 1-11:30pm schedule. This role is focusing on drug substance (bulk manufacturing operations). 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 Wednesday - Saturday, 1-11:30pm. 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) 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 step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

          For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

          Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

          Salary Range (hourly)$26.73 - $48.08

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