Description

Support of routine bioanalytical testing of samples from cell-line development, in-process, process development/characterization, forced degradation, release & stability, and pre-formulation studies. Other potential opportunities include method development/optimization, workflow optimization, and template development.

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

Qualifications

• BS (5+ yrs) or MS (2+ yrs) of relevant experience in analytical chemistry and/or biologics testing laboratory

Required Skills and Experience

• Must have separations experience for large molecules

• Experience in analyzing biologics including monoclonal antibodies and/or other therapeutic proteins using at least one of the following techniques:

• Liquid Chromatography (HPLC / UPLC), such as 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)

Desired Skills and Experience

• High-throughput liquid handling systems such as Tecan, Bravo, Gilson etc.

• Familiarity with compendial testing such as UV 280, pH, and Physical Observations

• Ability to follow complicated scientific protocols / procedures

• Making accurate reagent preparations (dilutions / solutions / buffers / mobile phases)

• Good documentation practices and utilization in electronic laboratory notebooks (ELN)

• Analytical software including Empower and/or Chemstation

• Knowledge of Laboratory Information Management Systems (LIMS)

• Familiarity with Microsoft Office Applications (Outlook, Excel, Word, PowerPoint, OneNote, Teams, etc.)

About Parexel FSP

The CMC Operations group is part of Parexel FSP. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us!