Associate Director Quality Control (Lab Support)

Rensselaer, New York
Mar 20, 2018
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: Accountable for the leadership activities and directing all facets of Quality Control Lab Support activities, including but not limited to: Sample Management, reference standard, and supply Management, Equipment Management, Certificate of analysis generation, QC Data trending analysis, cGMP compliance, Interaction with regulatory bodies. Responsible for Building effective systems, processes, teams, and managing through them for a smooth lab operation.

Essential Duties and Responsibilities include, but are not limited to the following:
• Oversee day to day operation of QC Lab Support (QC Equipment, CoA, and Data trending, QC reference standard, and QC sample and supply management). Accountable for timely equipment qualification and maintenance, timely CoA issuance, data trend analysis and investigation, reference standard distribution, qualification and inventory management, samples distribution to the lab in a compliant manner, and lab supply inventory management.
• Ensure safety, cleanliness, and compliance (SCC) at all time.
• Provide technical expertise for personnel training, deviations, CAPA, inventory management, cGMP compliance, data trending.
• Provide leadership and direction to Quality Control supervisors and Managers and support teams to ensure high quality service.
• Lead lab support topics in inspections conducted by external regulators and business partners.
• Organize scientific data trend review, interpret data and draw reasonable conclusions.
• Advise Manufacturing, QA, RA, Facilities and Material Management of Lab support requirements and issues associated with service provided.
• Provides key leadership, vision and direction to the QC Lab Support group while providing operational and technical expertise.
• Establish department operation schedule, plans, processes, budgets, departmental strategies, goals, objectives and metrics (Business continuity and long-term planning).
• Excellent managerial skills as well as problem solving skills. Handle issues appropriately and with a sense of urgency.
• Manage and develop direct reports by setting clear expectations, as well as resolving conflicts.
• Excellent communication skills: Ensuring timely issue escalation to Quality senior management and cross-functional support teams.
• Drive Continuous Improvement.
• Represents the department during high-level discussions and investigations with external customers, vendors and FDA representatives.
• Serve as a role model for behavior that is consistent with the mission, vision and values of the Regeneron organization with respect to the regeneron success factor: Trust, Respect, Teamwork, Transparency, and continuous improvement.

Knowledge, Skills and Abilities:
•Ability to maintain integrity and honesty at all times
•Ability to communicate and lead with transparency
•Lead department for optimal performance and set course for future
•Accountable for performance and results of department
•Ability to influence outside of own department
•Evolving knowledge of global organization and industry trends

Education and Experience:
• Requires minimum BA/BS in Biochemistry, Chemistry or related field with 10+ years experience in the biotech or pharmaceutical industry. Management experience in Quality Control required. MS/MA 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.

Requisition Number: 10390BR