BA/BS (6 yrs.) of relevant experience in analytical chemistry or biologics testing lab
MS (4 yrs.) of relevant experience in analytical chemistry or biologics testing lab
Ph.D. (1-2 yrs.) of relevant experience in analytical chemistry or biologics testing lab
Required Skills And Experience
Must have separations experience for large molecules or plate-based assay experience.
Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques:
Liquid Chromatography (HPLC / UPLC)
Protein A Titer, Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX, AEX, CEX), Reverse Phase (RP), or Hydrophobic interaction chromatography (HIC)
Electrophoretic methods such as capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and/or capillary isoelectric focusing (cIEF)
Basic instrumentation troubleshooting
Ability and willingness to train and follow laboratory methods and procedures
Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.)
Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases)
Good documentation practices & utilization in electronic lab notebooks (ELN)
Desired Skills And Experience
Analytical software such as Empower.
Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using plate-based methods, e.g., ELISA (HCP, proA)
Familiarity with compendial testing such as UV 280, pH, and Physical Observations
Notes:
Open to bachelor, masters, and/or PhD level.
100% onsite lab based role.
Required to have direct expertise in operating LC and CE analytical systems for testing large molecules in an industry or CRO environment.
Required to be experienced in the industry, with ability to quickly train on *-specific procedures and start working in the lab.
Role will involve high volume sample testing across multiple preclinical and clinical stage biologics programs, including proteins and antibody-drug conjugates.
Required to follow all safety, compliance and quality practices.
Required to understand and follow good documentation practices within an electronic laboratory notebook.
Required to have strong communication skills, ability to collaborate, and ability to work independently.
Description Support of routine Biologics analytical testing of samples from cell-line development, in-process, process development/characterization, forced degradation, release & stability, and pre-formulation. Responsibilities
Support of high-throughput, pre-formulation, pre-qualification, robustness, or admixture testing
Results processing and documentation by following appropriate methods / protocols / procedures
Sample management and monitoring of controlled temperature units.
Following all appropriate laboratory safety and hygiene procedures.