Analytical Specialist (Extractables & Leachables) at Regeneron Pharmaceuticals, Inc.

Regeneron is currently looking for an Analytical Specialist for our QC Analytical Sciences Extractables and Leachables (E&L) team. This is a non-lab based position. The Analytical Specialist collaborates with cross functional units across the company, including Manufacturing, Process Sciences (PS), Quality Control (QC), CMC Regulatory Sciences, and Quality Assurance (QA) to provide scientific expertise and deliverables related to study design, new products, and change management.

As an Analytical Specialist, a typical day might include the following:

• Managing analytical projects and deliverables to support pre and post marketing regulatory commitment deadlines, and development of new projects and studies.
• Serve as a technical resource for data interpretation and results of extractable and leachable studies of polymeric and elastomeric materials.
• Summarize and explain the results of laboratory studies from different analytical techniques such as UPLC, GC, ICP, and Mass Spectrometry to cross functional management.
• Evaluate new polymeric and elastomeric components for use in GMP production.
• Organize and lead meetings to facilitate knowledge management and drive project timelines.
• Represent the department in cross functional meetings to establish projects, and build and maintain relationships with team members from early development through post marketing.
• Author and review technical documents, whitepapers, and SOPs.
• Proactively review relevant industry and agency guidelines as they apply to extractables and leachables.

This role might be for you if:

• You have previous experience or background in analytical testing and/or method development and wish to shift your career toward program management, cross functional collaboration and/or technical writing.
• You prefer to work independently, have strong analytical thinking skills, and can take multiple priorities and translate them to project completion.
• You possess excellent interpersonal skills (including presentations and writing skills).
• You enjoy working within a team to actively participate in discussion, program planning, and continuous learning based on the business needs and regulatory expectations.
• You enjoy the challenge to adjust strategies based on new situations and appreciate a culture where continuous improvement is not just a metric.
• You are careful and diligent in authoring and reviewing GMP documents.

To be considered for the Analytical Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BA/BS in chemistry, biology or related field. For various levels you must have the following:

Analytical Specialist: 2+ years of relevant experience

Sr. Analytical Specialist: 5+ years or relevant experience

Previous experience in analytical testing and method development or equivalent extractable and leachable experience is preferred. Prior laboratory experience is required. Level is determined based on qualifications relevant to the role.

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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 (annually)