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 duties to support chain of custody for raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment.
Reporting to the Lead QC Analyst, the person will be responsible for the following;
- Oversees and maintains appropriate procedures to ensure chain of custody for QC samples is maintained.
- Ensures a high level of customer service for teams submitting samples for QC, including customer queries.
- Participation in cross functional site meetings.
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
- Participates in training of other new employees and prioritizes workloads on a daily basis.
- May enter a Laboratory Cleanroom to collect and log samples for analysis.
- May perform analysis in accordance with standard operating procedures (SOPs).
- 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.
- 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 procedures.
- 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.
- Certificate / Diploma in a scientific/technical discipline.
- 1 – 2 years hands-on work experience in a regulated QC laboratory within the biopharmaceutical industry.
- Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc., is an advantage.
- Excellent communication skills, both verbal & written.
- 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 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.