Sr. Manager Quality Control (Clinical) - Albany, NY | Biospace
Get Our FREE Industry eNewsletter

Sr. Manager Quality Control (Clinical)

Regeneron Pharmaceuticals, Inc.

Albany, NY
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Manage QC Analytical Science routine testing functions, to encompass Drug Substance and Drug Product release and stability testing for Phase I and Phase II drug programs as well providing analytical support to the Process Sciences (PS) department to complete process validation analytical testing for late stage candidates.

Essential Duties and Responsibilities may include, but are not limited to, the following:
* Manage multiple groups within department focused on routine testing
* Set laboratory testing schedule and communicate to reports and across organization
* Represent Analytical Sciences at interdepartmental deviation meeting. Set strategy for resolving department deviations. Update senior management as needed on progress
* Ensure data is reviewed and authorized in a timely manner
* Ensure GMP compliance within the group
* Lead laboratory investigations, driving to root cause
* Perform job duties with little to no direction from supervisor. Able to navigate ambiguity and changing priorities
* Strive for continuous improvement and operational efficiency within the group
* Work with QC project management and other functions to determine sample forecast and priority
* Maximize analyst and instrument productivity
* Write group SOPs and provides drafts of proposed test methods to QC
* Transfer methods to commercial QC organization
* Keep laboratory in inspection ready state

Knowledge, skills and Abilities:
*Solid supervision and leadership skills
*Ability to interpret and communicate information
*Ability to prioritize, manage multiple tasks, and meet deadlines


Education and Experience:

* Requires BS/BA in a scientific or engineering field and 8-10 years relevant experience, including 3-5 years of management experience.
Experience in a Chemistry, Biochemistry, or Bioengineering QC laboratory required.

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.