Lead QC Analyst Bioassay

Location
Rensselaer, New York, US
Posted
Jul 13, 2018
Ref
13563BR
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.

Schedules are:
Tues-Sat 1st shift
Mon-Fri 2nd shift

Summary: Performs biological analyses in a GMP environment on products, in-process materials, or stability samples in support of the company's quality program.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Performs potency testing using cell based bioassays and binding ELISA assays.

• Maintains cell lines using aseptic technique and good cell culture practices.

• Maintains laboratory supplies.

• Reviews and updates control test procedures and SOPs.

• Performs deviation and laboratory investigations.

• Complies with all pertinent regulatory agency requirements.

• Participates in required training activities.

• Gathers data and documents test results.

• Completes test records and reviews data; reports any quality anomalies.

• Calibrates or verifies calibration of instruments/devices prior to use.

• May be responsible for maintaining a specific project.

• May assist in validation and/or development of new analytical methods and techniques.

• May be involved in establishing the transfer of methodology from R&D.

• May participate in the qualification of QC laboratory equipment.

Individuals in the Lead role will continue performing their daily tasks and responsibilities and will take on the following lead related responsibilities:

• Provides on-the-floor guidance and support to employees;

• Ensures employees timesheets are completed on time;

• Monitors employees training to ensure that all requirements are met, including OJT.

• Maintain up to date training records for self and direct reports.

• Perform minimally monthly performance feedback meetings with direct reports;

• Escalates all performance issues to management and/or HR;

Knowledge, skills and abilities:

• Ability to prioritize, manage multiple tasks, and meet deadlines.

• Ability to organize and maintain data or information.

• Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.

• Ability to learn through observation and hands on experience.

• Anticipates and plans for change

• Critical thinking skills

• Demonstrates analytical skills through problem-solving

• Demonstrates leadership by being approachable

• Participates in projects in addition to daily responsibilities

Education and Experience:

• Requires BS/BA in Life Sciences or related field; will substitute relevant experience for education. For a level III or higher, a minimum of 5+ years' relevant experience, preferably working in a cGMP pharmaceutical environment, is required.

• Previous experience with cell culture practices preferred.

• Experience with bioassay and/or binding assay testing strongly preferred.

• Previous experience in a GMP/GLP environment preferred but not required.

*Level to be determined based upon 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.

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