QC External Laboratory Coordinator

Location
Rensselaer, New York
Posted
Mar 22, 2018
Ref
12669BR
Required Education
Masters Degree/MBA
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Coordinate sample management and method transfer activities to external laboratories for a wide variety of microbial and analytical assays to support raw material, utilities, in-process, bulk drug substance and drug product manufacture testing in a cGMP regulatory environment.

Essential Duties and Responsibilities: Reporting to the QC External Laboratory Manager, the person will be responsible for the following;
• Plan, prioritize and coordinate sample management and method transfer activities to external laboratories for a wide variety of microbial and analytical techniques to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment.
• Use a sample tracking system (LIMS) to review sample inventory against samples sent and received by the external laboratories to determine accuracy and to maintain sample integrity.
• Work as part of a team to ensure that samples are delivered to the laboratories on-time.
• Coordinate the issuance and approval of Quality Agreements with the contract labs. Author Master Service Agreements, as necessary.
• Participates as required by QA in GMP audits to the contract labs.
• Document and communicate discrepancies to appropriate personnel in a timely and efficient manner.
• Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
• Review and approve method transfer validation protocols and reports.
• Coordinate the external laboratories and Regeneron subject matter experts (SMEs) in troubleshooting and identifying root cause analysis and providing technical advice as needed in support of invalid assays, deviations, OOS/OOT investigations.
• Initiates and completes CAPAs and Change Controls in accordance with site procedures.
• Writes new and updates current SOPs as needed.
• Proactively identifies and implements process improvements, lean initiatives.
• Performs other duties relevant to the position as required.

Knowledge and Skills:
• Excellent written and oral communication skills.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Ability to organize and maintain data or information.
• Ability to learn through observation and hands on experience.
• Good time management and attention to detail.
Education and Experience:
• BS degree or higher in biology, chemistry, microbiology or related field. Preferably with 2+ years hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry.
• Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, etc., is an advantage.
• Adaptable and flexible, as position will require some travel.
• Collaboration and team work. Maintains the highest standards of ethical behavior.
• Strong analytical ability and associated problem solving.
• Knowledge and proficient in the use of Microsoft products including, Project, Excel, Word and PowerPoint.

*Title level will be determined based on skills and experience.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 12669BR