QC Analytical Specialist

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: Support the Manufacturing, Process Sciences (PS) and Quality Control (QC) departments through the development, optimization, troubleshooting, validation, transfer and application of analytical test procedures, and clinical product testing as needed.

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

• Establish, develop, and/or optimize analytical methodology to test the identity, strength, purity, potency and stability of protein products (in-process and final).

• Establish, develop, and/or optimize analytical methodology to test the identity and concentration of impurities (product-related and process-related).

• Establish, develop, and/or optimize analytical methodology to test the identity and purity of raw materials.

• Gather, compile, and analyze historical data to evaluate product and method performance, and identify trends.

• Optimize and prepare analytical test methods for commercialization.

• Develop and write protocols for assay qualification/validation studies and analytical SOPs for product testing.

• Perform assay qualification/validation experiments.

• Tabulate results and write summary reports of assay development and validation studies.

• Transfer new or improved control test procedures to customer groups.

• Troubleshoot established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems.

• Present findings at group and possibly at interdepartmental meetings.

• Maintain lab supplies and equipment for GMP compliance.

• Produce and maintain accurate records.

• Write departmental SOPs and provides drafts of proposed test methods to QC.

• Train other members of the team

Knowledge, Skills & Abilities:

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Ability to clearly communicate information and decisions to outside parties

• Continuously drive to improve processes for improved performance

• Provides training and guidance to others

• 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:
Education and Experience:
Requires BS/BA in Chemistry, Biochemistry, Biology or related field, and a minimum of 5 years of progressive experience working in a cGMP pharmaceutical environment. Testing experience should include ELISAs, DNA by PCR, Gel Electrophoresis or HPLC assays and Isoelectric focusing.
May substitute higher education in lieu of years of 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.