Analytical Specialist

Rensselaer, New York, US
Jul 13, 2018
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.

Summary: Support the Combination Products (CP) department through the development, optimization, troubleshooting, validation, transfer and application of analytical test procedures. Support drug product process development through the performance of analytical tests.

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 (research, development, in-process and final), including those packaged into primary containers.

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

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

• Perform assay qualification/validation experiments.

• Perform material testing as needed.

• Interact with engineering and materials scientist groups to select appropriate testing techniques for primary container and contact material compatibility studies.

• Troubleshoot established test methods. Provide analytical support for filling process development and for troubleshooting process, formulation, and container 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 interdepartmental meetings.

• Maintain lab supplies and equipment.

• Produce and maintain accurate records.

• Train lower level group members.

Knowledge, Skills and Abilities:

• Knowledge of biochemical analytical techniques, including liquid chromatography, particle analysis, and charge variant (IEF) methods.

• Ability to set up, characterize, and document new analytical systems. Ability to train peers on same.

• Ability to maintain integrity and honesty at all times.

• Ability to work independently or as part of a team.

• Ability to communicate with transparency.

• Continuously drive to improve processes for improved performance.

• Demonstrate respectful behavior at all times.

• Ability to learn and follow routine procedures independently.

• Basic troubleshooting skills.

• Identify and communicate continuous improvement ideas.

• Ability to work in an every-changing environment.

• Build and maintain working relationships.

• Goes above and beyond by demonstrating proficiencies with assigned tasks.

• Ability to gather, generate, and interpret data.

• Participates in projects.
Education and Experience:

• Requires BS/BA in Chemistry, Biology or related field for level I; progressive experience working in a pharmaceutical environment required for subsequent levels. May substitute relevant experience in lieu of educational requirement.

• MS preferred. Experience with 5S, Six Sigma, or other continuous improvement programs preferred. Experience working in collaboration with device engineering teams preferred.

**Level will 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.