- Design and Execution of laboratory experiments to support development, validation and transfer of analytical methods for monitoring process related impurities (ex. Host Cell Proteins, residual ProA, DNA) in Biologics. Author, review and/or approve technical documents or regulatory filings ensuring high technical standards and compliance with applicable regulatory guidelines to support analytical impurity methods (protocols, reports, test methods, regulatory filings, etc). Evaluation / Implementation of new technologies.
- Able to work independently with minimal supervision. Competent in multiple analytical techniques with advanced knowledge in at least one relevant technique (plate based assays, ELISA, qPCR, western blot/gel-electrophoretic methods).
POSITION ACCOUNTABILITIES
- Development, validation and transfer of analytical impurity methods to support Biological product release (60%)
- Execution of laboratory experiments to support development and validation of analytical methods for process related impurities for Biologics programs.
- Planning, designing, and conducting experiments and data analysis to support the development and validation of process related impurity methods.
- Supporting troubleshooting and assay remediation activities with strong technical expertise in plate based impurity methods and fundamental understanding of analytical development principles.
- Support in the lab or oversee characterization of critical reagents (Antibodies, conjugated antibodies, assay controls, calibration standards) using a variety of fundamental biochemical methods including ELISA, 1 and 2 D gel electrophoresis methods, western blot, HPLC and LCMS methods and protein concentration determination.
- Author, review and/or approve technical documents (protocols, reports, test methods, etc) or regulatory filings ensuring high technical standards and compliance with applicable regulatory guidelines to support analytical impurity methods related to Biologics (30%)
- Responsible for documentation of development and validation data, generation of high-quality written study protocols, reports, and participating in cross functional meetings.
- Responsible for maintaining awareness of current regulatory guidelines that may apply to methods being validated (ICH quality guidelines etc).
Degree in Chemistry, Biochemistry, Biology or other related discipline with minimum additional years of relevant industry experience in Analytical Development or related function:
- BSc and 3-4 yrs industry experience
- MSc and of 1-2 yrs industry experience
Key areas of expertise and competencies:
- Hands on experience working on development of plate based impurity methods including process specific host cell protein (HCP) ELISA, residual DNA methods (qPCR, dPCR), residual Protein A methods, Octet methods and related technologies.
- Experience in overseeing or performing critical reagent generation, characterization and qualification for use in Process related impurity assays (Antibodies and conjugated antibodies, enzyme substrates, assay controls, calibration standards etc).
- Has sufficient expertise in multiple relevant laboratory technologies to be a functional area resource and trainer for more junior scientists.
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Lexington, MA are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
