Job Description

Pay 80-93/h depending on experience

The ideal candidate is responsible for overseeing the development, validation, and implementation of PK, immunogenicity, and cell based assays in both the regulated and non-regulated environment to support biologics drug candidates in pre-clinical and clinical development.  This is a fully remote position with the candidate responsible for managing CROs and CMOs to develop, validate, and execute bioanalytical and cell-based potency assays, and for interpreting and reporting bioanalytical results to support drug discovery and clinical development activities.

This position will collaborate closely with internal cross-functional departments, including analytical method development/characterization, process development, manufacturing operations, research, development, and quality assurance, to achieve corporate goals and objectives. The individual will represent the bioanalytical department in cross-functional discussions and present scientific findings at team meeting. This position will also require working closely with multiple external contract organizations including CMOs and Contract Laboratories in the areas of method transfer, qualification/validation and implementation of QC methods, with focus on plate-based and cell-based assays, including PK, immunogenicity, potency methods for lot release, and stability studies. 

The successful candidate must be proficient in biological assay development (ELISA and cell-based) and be proficient in Quality Control execution and systems, stability study programs, method development/qualification/validation, and end to end CMC regulatory drug approval process for biologic drug substances and drug products.

Requirements:

A minimum of a Masters’s degree in a biology/biochemistry discipline is required. Advanced degree such as PhD is preferred. A minimum of 5 years previous biotechnology/pharmaceutical industry experience is required.

Knowledge and hands-on experience with method development, qualification, and validation of cell-based bioassay for potency measurement to support GMP manufacture, product characterization, lot release, and stability testing are required. Experience in cGxP and quality is desirable.  Prior experience managing CROs required. Excellent written and verbal communication skills are required.

Must have in-depth knowledge and hands-on experience in plate-based and cell-based assay development, execution and troubleshooting, as well as expert knowledge of methods and immunoassay technologies, such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, Electrochemiluminescence (MSD), etc. to support animal and clinical studies.  Experience with developing automated sample handling and assay processes is desirable. Knowledge of GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is desirable.  

A thorough knowledge and experience working in a cGMP environment is desirable. A thorough working knowledge of FDA, ISO and cGMP requirements for areas of responsibilities and project management experience is a plus.  

Job Tags

Remote job, Contract work,

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