Associate Director Quality Control (Biochemistry)

Rensselaer, NY, US
Mar 02, 2018
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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: Direct QC biochemistry laboratory operations and GMP compliance within assigned area(s).

Essential Duties and Responsibilities include, but are not limited to, the following:
• Oversee QC biochemistry testing operation to support product release, stability testing and in-process control, product investigation and assay validation under cGMP.
• Provide work planning and operational 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.
• Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
• Characterization/optimization/validation of cell-based potency assays, binding assays.
• 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 performance evaluations and recommendations.
• Prepare and host regulatory inspections for QC and address analytical issues during inspections and regulatory filing.
• Performs personnel management functions including coaching, personnel development, and performance evaluations.
• Work with members of Manufacturing, QA, RA and R/D to provide quality control guidance and technical support for product release, stability shelf-life determination, process validation, regulatory filing and side-wide compliance.

Knowledge, Skills and Abilities:
•Ability to maintain integrity and honesty at all times
•Ability to work independently or as part of a team
•Ability to communicate with transparency
•Continuously drive to improve processes for improved performance
•Demonstrate respectful behavior at all times
•Lead department for optimal performance and set course for future
•Accountable for performance and results of department
•Business continuity and long-term planning
•Ability to influence outside of own department
•Create departmental goals and assign resources based on business needs
•Effectively communicate vision for department
•Lead by example; be a team player
•Lead with transparency
•Diagnose status of organization and positively impact culture
•Evolving knowledge of global organization and industry trends

Education and Experience:
• BS/BA required; advanced degree preferred, in biochemistry or related field with a strong background in laboratory management and bio analytical sciences. 10+ years experience in the biotech or pharmaceutical industry with minimum 7 years of management experience in QC/Analytical laboratory required. Advanced degree preferred.

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.