Sr. Manager Quality Control (Biological Testing)

Location
Rensselaer, New York
Posted
Apr 19, 2018
Ref
10170BR
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
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: Manage the Biology Laboratory with technical responsibility for all contaminant assays and aspects of QC testing.

Essential Duties and Responsibilities include, but are not limited to, the following:
•Provide work planning and technical guidance to lab personnel and technical review.
•Data analysis and review and release of product.
•Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
•Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
•Author technical and regulatory reports, SOPs, TCRs, CAPAs and MCs.
•Perform investigations for OOS deviations.
•Co-manage quality system for monitoring OOS results, atypical results and invalid tests.
•Provide information to investigators as needed during regulatory audits
•Ensure quality and regulatory compliance.
•Prepares annual employee evaluations and recommendations.
•Provide support to the Scientist(s) performing assay development and validation.

Knowledge, Skills and Abilities:
•Ability to lead and be accountable for team's performance and results
•Manage internal and external relationships
•Develop strategy and create metrics to measure effectiveness of strategy
•Lead through ambiguity and translate into actionable steps
•Provide leadership to direct and indirect reports
•Coaching and conflict resolution
•Handle issues appropriately and with a sense of urgency
•Prioritize based on business needs
•Identify and effectively communicate risks
•Ability to problem solve and identify root cause
•Ability to communicate at all levels and across various functions
•Ability to build, lead, and motivate team

Education and Experience:
•Requires BS/BA in Biology, Biochemistry, or related field. Advanced degree preferred.
•Requires 8+ years of biotech or pharmaceutical laboratory experience, including 3-5 years of management 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: 10170BR