QC Analytical Specialist

Rensselaer, NY, United States
Feb 22, 2019
Required Education
Bachelors Degree
Position Type
Full time
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 support of chemical identification investigations. 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:

• Execute investigation testing for the chemical identification of unknown material for manufacturing, process sciences or quality control support.

• Evaluate/interrupt data and co-author memos for investigational testing.

• Establish, develop, and/or optimize analytical methodology for the analysis of unknown compounds/contaminates/debris. At times in varying matrices or particle size.

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

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

• Perform assay qualification/validation experiments.

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

• Assist in the analysis of samples generated from lab scale process studies.

• Assist in product failure or customer complaint investigations

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

• 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 lower level group members.
Knowledge and Skills:

• Excellent written and oral communication skills.

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

• Ability to organize and maintain accurate data or information.

• Ability to learn through observation and hands on experience.

• Hand/eye coordination and fine motor skills required.

• Ability to work alone or in group settings.

Education and Experience:

• Requires BS/BA in Chemistry, Biology or related field and 2+ years' related experience. Experience working in a cGMP pharmaceutical environment preferred. May substitute relevant experience in lieu of educational requirement.

*Level will be determined by education and 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.