Employee Responsibilities include, but are not limited to:
Responsible for executing basic/routine data review/analysis and unit operations under supervision.
Assists in the planning of basic unit operations
Performs stability coordination
Initiates OOS/ATI/Investigations
Liaisons with vendor test laboratories.
This will not be a lab position.
The Ideal Candidate would possess:
Strong technical knowledge and experience in Biologics QC requirements, including, but not limited to the following, Cation-Exchange Chromatography (CEX), Capillary Isoelectric Focusing (iCEF), SDS-PAGE, Capillary electrophoresis- SDS (CE-SDS), Size Exclusion Chromatography (SEC), Binding Efficacy, cell-based bioassays, ELISA, Residual CHO DNA by qPCR, RP-HPLC, Gas Chromatography, Karl Fischer titration, UV Spectrophotometry, FTIR, Protein concentration by UV spectrometry, sub-visible particles testing by light obscuration/microscopy, Endotoxin LAL, Sterility, and Bioburden.
Solid understanding of Quality Control CMC requirements for Biologics IND, BLA, and other global regulatory filings.
Strong working knowledge of QC and GMP compliance.
Proficiency with electronic documentation (such as LIMS, learning management system, excursions management system).
Proficiency in stability data trending using statistical tools.
Minimum Qualifications:
Bachelor's degree in chemistry, Biology or equivalent with 2+ years' relevant industry experience
Previous experience in Quality Control and/or Analytical Development preferred
Authorization to work in the United States indefinitely without restriction or sponsorship.
What we offer:
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
Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of Cambridge, Massachusetts are encouraged to apply.
Eurofins Lancaster Laboratories Professional Scientific Services ® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
