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: Perform assay development, characterization, optimization, transfer, validation and investigation for QC group. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Perform assay development/validation for QC Chemistry group.
• Review new test procedures and assays.
• May evaluate and bring in new methodologies/techniques when needed.
• Facilitate assay transfer from R&D and to business partners.
• Organize analytical assay transfer internally and externally.
• Set product specifications.
• Participate in technical troubleshooting and problem investigation.
• Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
• Participate in training programs for analysts.
Knowledge and skills:
• Ability to work independently or on a team.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
• 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.
• Accountable for technical performance and results of team.
• Manage internal and external relationships.
• Develop strategy and create metrics to measure effectiveness of strategy.
• Translate ambiguity into actionable steps.
• May manage others through influence rather than direct authority.
• Ability to resolve conflicts and coach others on problem solving.
• Handle issues appropriately and with a sense of urgency.
• Prioritize based on business needs.
• Identify and effectively communicate risks.
• Ability to problem solve and identify root cause.
• Ability to communicate at all levels and across various functions.
Education and Experience:
• Requires Ph.D in Biochemistry, Chemistry, Biology or related field with a minimum of 2 years of experience; may consider another degree discipline. Position level with commensurate experience;
• cGMP experience is desirable.
• Experience with the following is also preferred:
o Charge heterogeneity characterization and analysis using Isoelectric Focusing (IEF) and or Imaged Capillary Isoelectric Focusing (iCIEF).
o Familiarity or working knowledge of Lab Chip based Purity analysis and quantitation.
o Purity/ Impurity and glycan analysis using capillary based PA800 Plus system.
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.
Requisition Number: 12955BR