CMC Scientist

Rensselaer, New York, US
Sep 02, 2018
Required Education
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: This individual will provide scientific assistance in formulating sound technical positions and documentation that support meeting departmental responsibilities and achieving IOPS regulatory and business goals.

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

• Participates on study teams for investigations and comparability studies.

• Authors and reviews technical reports of biopharmaceutical production processes and to support regulatory filings.

• Reviews regulatory submissions, from a scientific perspective, to identify potential red flags that need further discussion with subject matter experts.

• Assists CMC Regulatory Sciences Specialists with writing responses to agency information requests, when needed.

• Participates in CMC technical problem solving discussions affecting regulatory submissions and develops the technical description of this information within regulatory documents.

• Reviews product specifications to ensure methods and criteria are accurate.

• Works cross-functionally to engage and understand developing biopharmaceutical technologies and helps prepare an appropriate regulatory approach for their introduction.

Knowledge and Skills:

• Knowledge of biopharmaceutical manufacturing processes, including validation and comparability studies.

• Excellent scientific writing and communication skills.

• Hands-on experience with a wide variety of bio/physico/chemical analyses including chromatographic, spectroscopic and electrophoretic methods.

• Good working knowledge of basic statistics.

• Familiarity with protein chemistry and stability pathways.

• Demonstrated history of consensus building and collaboration.
Education and Experience:

• PhD in chemical or biochemical engineering, biochemistry or chemistry required. PhD in a related field may be considered.

• 3-5 years of broad research experience working in the biopharmaceutical, pharmaceutical or chemical industry is preferred.

Title level (CMC Scientist or Senior CMC Scientist) will be determined based on skills 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.