Extractable& Leachable Specialist- Quality Control

Rensselaer, New York
Jun 18, 2022
Required Education
Bachelors Degree
Position Type

Regeneron is currently looking for and Extractable& Leachable Specialist for our Quality Control (QC) Analytical Sciences team. The QC Extractables & Leachables (EL) Specialist plays a meaningful role to support cross functional units across the company, including Manufacturing, Process Sciences (PS), Quality Control (QC), CMC Regulatory Sciences, and Quality Assurance (QA), by providing program management for EL studies, scientific supports for study design, and documentation for business goals. . This is a non-lab role.

As a QC Extractable& Leachable Specialist, a typical day might include the following:

  • Responsible for managing projects and timelines and ensuring results are completed to meet deadlines. This includes projects related to analytical commitments for Regulatory filings (both pre and post marketing), follow-up actions for GMP (Good Manufacturing Practices) inspections, and development projects and studies.
  • Supervise and monitor project timelines by coordinating meetings and performance-enhancement platform
  • 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 such as risk assessments for single use polymeric raw materials used in the manufacturing process.

This role might be for you if:
  • You have previous experience or background in routine analytical testing and/or method development, but wish to shift your career toward program management and/or technical writing.
  • You possess excellent interpersonal skills (including public speaking, presentations, and writing skills).
  • You enjoy working within a team to actively participate 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 can take a proactive and self-disciplined approach to prioritize projects to meet established goals.
  • You are a careful and diligent in authoring and reviewing GMP documents.

To be considered for the QC Extractable& Leachable Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm. For various levels you must have the following:

Associate QC Extractable& Leachable Specialist: BA/BS in chemistry, biology or related field and

QC Extractable& Leachable Specialist: BA/BS in chemistry, biology or related field and 2+ years of relevant experience.

Sr. QC Extractable& Leachable Specialist: BA/BS in chemistry, biology or related field and 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 preferred. Level is determined based on qualifications relevant to the role.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.