Extractable& Leachable Specialist- Qualtiy Control

Location
Rensselaer, New York
Posted
May 19, 2022
Ref
REGEA0026R11358
Required Education
Bachelors Degree
Position Type
Contract

Regeneron is currently looking for aa Quality Control (QC) Extractable & Leachables (EL) Specialist with Monday – Friday 8:30 AM to 4:30 PM schedule. A QC EL Specialist plays a meaningful role to support function units across the company, including Manufacturing, Process Sciences (PS), 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), and actions for GMP inspections.
  • Author and review study protocols and reports for testing, technical documents such as risk assessments for single use polymeric raw materials used in the manufacturing process, controlled documents (e.g., SOPs, WIs, JAs, and Forms) for content updates or procedural improvements.
  • Conduct peer review of data and reports relating to area of expertise.
  • Facilitate testing of leachable studies by establishing and maintaining processes for sample chain of custody.
  • Perform impact assessment for change notifications and change controls; contribute to risk assessment process and implement actions as needed.
  • Track and monitor project timelines by coordinating meetings and other performance-enhancement platform.
  • Prepare, distribute & present project status reports and meeting minutes to project team members and management.
  • Represent the department in cross functional meetings to establish projects, and build and maintain relationships with team members from early development through post marketing.
  • Develop scientific arguments for white paper justifications and conclusions using available literature and laboratory data.
  • Initiate and implement special projects as assigned to improve programs; Craft and maintain database to facilitate investigation.
  • Maintain awareness and detailed understanding of current regulations to ensure compliance.
  • Attend conferences and presentations to maintain an innovative program.
  • Identify appropriate contract lab for outsourced testing and interact with contract lab as the primary contact person.
  • Support and participate internal, partner and regulatory audits.
This role might be for you if:
  • You have previous experience or background in routine analytical testing and/or method development
  • You possess excellent interpersonal skills (including inter-person, oral presentation, 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, rather a mentality for everyone to get better every day.
  • You can take a proactive and self-disciplined approach to prioritize projects to meet established goals.
  • You are a careful and diligent professional 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.