Lead QC Analyst Bioassay
|Posted on:||Friday, July 13, 2018|
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.
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:
• 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