Associate Scientist III- Protein Analytical Chemistry, CMC
We are seeking an Analytical Development Scientist with hands on experience in analytics to support CMC development of biotherapeutic proteins. In this lab based position you will conduct UV, CE, icIEF and HPLC/UHPLC testing of monoclonal antibodies, bispecific antibodies, and antibody drug conjugates. You will also contribute to the development of QC and characterization methods for these products.
Key Responsibilities Include:
• Perform analytical testing to support CMC development of therapeutic antibodies, antibody variants, and antibody drug conjugates (ADCs) including: UV concentration, capillary electrophoresis, icIEF, HPLC/UHPLC (SEC, IEX, RP, HIC, HILIC) and other wet lab techniques.
• Contribute to the development of CE, icIEF, and/or HPLC/UHPLC methods to characterize biotherapeutic proteins and their associated variants and impurities. Troubleshoot instrumentation and method issues.
• Validate and transfer QC release and stability methods to third party CMOs.
• Author test method SOPs, method validation protocols/reports, and technical reports.
• Present work and results in team and group meetings.
• BS in Chemistry, Biochemistry or related field with 6+ years of experience in the biopharmaceutical industry or MS with 3+ years industry experience.
• Must possess a solid understanding of protein chemistry and biochemistry, particularly as it relates to biotherapeutic protein drug development.
• Experience developing and performing capillary electrophoresis, icIEF, and/or HPLC/UHPLC (SEC, IEX, RP, HIC, HILIC) protein characterization assays.
• Experience with Empower software is preferred.
• Experience with CMC analytical development of monoclonal antibodies or related biotherapeutic proteins.
• Ability to learn new techniques, create and maintain accurate and complete records, follow instructions, attention to detail.
• Must have strong written and verbal communications skills.
• Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent assignments.
• Are you open to look at candidates willing to relocate? Yes at their own expense
• Work Schedule:? Mon-Fri
• Does this position offer the ability to work remotely on a regular basis or is it an on-site role? Mostly onsite, this is a lab based position
• Will there be Domestic and/or International Travel? NO
• Please define your required Interview Process: Phone screen-30 min with HM then move to second roung?Video Interview with panel of 30 mins total of 3 hours
• Is there anything that may prevent you from conducting interviews in a timely manner: No