Temporary-QC Chemistry Analyst

Recruiter
Regeneron Ireland
Employment Type
Temporary
Salary
Not disclosed
Regeneron Ireland logo

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.

Summary: Perform a wide variety of analytical chemistry testing to support in-process and bulk drug substance manufacture in a cGMP regulatory environment.

Essential Duties and Responsibilities include, but are not limited to, the following:

Reporting to the QC Chemistry Lead, the person will be responsible for the following;

  • Performing a wide variety of analytical chemistry testing to support in process and bulk drug substance release.
  • Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
  • Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
  • Maintains laboratory reagents and supplies.
  • Calibration of laboratory instruments.
  • Participates in the transfer of methodology from other test facilities.
  • Provides support and advice to manufacturing on QC related topics.
  • Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
  • Initiates and completes CAPAs and Change Controls in accordance with site procedure.
  • Writes new and updates current SOPs as needed.
  • Provides training to other analysts in the QC group.
  • Presents analytical data reports clearly and concisely to management.
  • Proactively identifies and implements lab process improvements, lean initiatives.
  • Performs other duties relevant to the QC laboratory position as required.

Knowledge Skills & Abilities:

  • HPLC
  • UPLC
  • UV-Vis spectrophotometry
  • Densitometry
  • Wet chemistry testing techniques including pH, conductivity, appearance and osmolality
  • Familiar with USP, JP and EP methodology

Education and Experience:

  • A third level qualification in a scientific/technical discipline.
  • At least 1 year hands-on work experience in a regulated QC laboratory-testing environment within the biopharmaceutical/pharmaceutical industry.
  • Excellent Communication skills, both verbal & written.
  • Experience with electronic systems such as LIMS, Empower, Qumas, eDoc, Trackwise etc., is an advantage.
  • Adaptable and flexible, willing to travel when needed.
  • Collaboration and team work. Maintains the highest standards of ethical behaviour.
  • Results and performance driven.
  • Strong analytical ability and associated problem solving.
  • Good time management and attention to detail.
  • Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.

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 excellent benefits including health and wellness programs, fitness centres 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.

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