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Manufacturing Specialist I- Regeneron Cell Medicines

Regeneron
Cambridge, MA Full Time
POSTED ON 2/1/2025
AVAILABLE BEFORE 3/2/2025
We are seeking an enthusiastic Manufacturing Specialist to join our successful internal manufacturing team as part of our broader Regeneron Cell Medicines (RCM) group. You will contribute your cell therapy manufacturing expertise in process operations, documentation and review, material safety, compliance, and directly support the advancement of our clinical portfolio. We hope you are excited to support cross functional and collaborative work to deliver therapies that transform the lives of patients.

As a Manufacturing Specialist I, a typical day might include:

  • Performing all tasks related to clinical manufacturing in clean rooms (ISO 7/ISO 5)
  • Following and completing Batch Production Records in a timely manner
  • Adhering to Standard Operating Procedures (SOPs), Work Instructions (WI) and other manufacturing guidance documents
  • Reviewing batch documentation and logbooks for completeness and accuracy
  • Performing cleaning and maintenance of manufacturing equipment and areas
  • Assisting in maintenance of manufacturing materials inventory
  • Performing area, equipment, and material preparation activities to maintain an operation-ready state
  • Authoring and revising documentation, including but not limited to SOPs, BPRs, logbooks, and others
  • Collaborating with various support groups (QC, QOps, MSAT, etc.) in deviation investigations and corrective actions, as well as launch and maintain site-improvement projects
  • Deliver on internal manufacturing goals, demonstrating experience in aseptic processing and cGMP regulatory requirements.

This Role May Be For You If You

  • Are able to be flexible and shift with changing priorities
  • Have the ability to work well in a team setting as well as independently
  • Enjoy collaborating with and learning from a subject matter expert’s guidance on production processes
  • Have a proactive mindset and continuously seek best practices and improves the team’s efficacy

In order to be considered for this role, you must have at least a HS diploma and 6 years or a Bachelor’s degree and 2 years of relevant experience. Must have experience working in pharmaceutical manufacturing. Experience working in cell therapy manufacturing is strongly advantageous. Must have working knowledge of Microsoft Suite. We hope you are excited to work collaboratively across functions to meet project milestones, with the goal to deliver therapies that transform the lives of patients.

Shift Requirements: Physical

  • Ability to perform physical requirements for entirety of shift
  • 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 including laundered undergarments, gown, facemask, hairnet, safety glasses, goggles, safety shoes and booties, latex gloves, and the use of sanitizing agents during gowning process including IPA) for extended periods of time.
  • Ability to remove jewelry, make-up, and nail adornments prior to wearing cleanroom attire

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)

$38.03 - $62.07

Salary : $38 - $62

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