Scientist, Analytical Development

Avid Bioservices•Tustin, CA

About The Position

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: In the Scientist, Analytical Development role you will have the opportunity to focus on developing cell-based, ELISA, HPLC, and/or CE methods and other analytical techniques to identify and characterize protein biologics. This position offers the chance to interface with project management, Process Development, Quality Control, as well as to interface with external clients. The Scientist will lead testing and sampling to support validation, process development, and stability studies in a non-GMP and GMP environment. Individual will take a product through method development and eventual transfer to a quality control department in a GMP environment. They will have a substantial understanding of the job and apply knowledge and skills to complete a wide range of tasks, as well as support and lead continuous improvement initiatives.

Requirements

BS degree in Biochemistry, Chemistry, Biology or a related field is required.
8+ years of biotech industry experience working in a QC or analytical lab.
Previous experience with analytical testing and equipment utilizing analytical biochemistry methods, writing reports/procedures/specifications, GMPs and regulatory audits required.
HPLC, CE, or Potency/ELISA experience is essential.
Should have also have experience with protein characterization, electrophoresis, chromatography, and assay validation/qualification.

Responsibilities

Develop, perform, troubleshoot and review routine wet chemistry/ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/CE/Maurice) and/or HPLC.
May be designated as study lead for validation projects, investigations, and method development projects.
Must use scientific reasoning when making decisions regarding the quality of the data reported.
Expected to research/gather information without supervision and to make scientifically sound decisions based on knowledge and experience.
Train/supervise the experimental work of more junior analysts.
Tabulate and graph data, and prepare technical reports for senior personnel.
Review technical data and reports written by less experienced personnel.
Manage client projects and collaboration with other functional areas including but not limited to MFG, QC, and PM.
Provide scientific insights for the joint team to make project decisions.
Develop, review, revise and write test methods, forms, templates and standard operating procedures and other related documents.
Actively support the QC department as the Subject Matter Expert (SME).
Knowledge of company cGMPs as well as industry regulations that apply to job functions.
Participate in regulatory inspections.
Support continuous improvement initiatives.
Other tasks as assigned.