Analytical Specialist- Quality Control (Cleaning)

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 biochemical test procedures, and clinical product testing as needed.

Level to be determined based on qualifications relevant to the role.

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

• Establish, develop, and/or optimize analytical methodology for biochemistry, bioassay, or chemistry-based assays including but not limited to ELISA, electrophoresis, or HPLC/UPLC analysis.

• Assist with product changeover studies

• Perform analysis on clinical release, in process and stability samples.

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

• Perform assay qualification/validation experiments.

• 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.

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

• 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.

Knowledge, Skills and Abilities:

• Excellent written and oral communication skills.

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

• Ability to organize and maintain data or information.

• Ability to learn through observation and hands on experience.

• 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 work independently

• Demonstrates strong written communication skills

• Advanced troubleshooting skills and ability to drive to root cause

• Builds collaboration cross-functionally

• Ability to forecast potential issues and provide proactive solutions

• Trains others to SME level

• May lead projects and manage complex initiatives

• Ability to question, interpret data and suggest alternatives

Education and Experience:

• Requires BS/BA in Biochemistry, Chemistry, Biology, or related field.

• May substitute relevant experience in lieu of educational requirement.

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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