Sr. Research Associate, Analytical Development

Avid Bioservices•Tustin, CA

About The Position

Avid Bioservices is seeking an experienced Sr. Research Associate to join its Analytical Development team, which develops protein biologics. The role focuses on developing and performing analytical methods, including cell-based, ELISA, HPLC, CE, PCR, and/or SDS-PAGE methods, to identify and characterize protein biologics. The associate works with analytical and process development scientists and interfaces with Quality Control as methods are transferred for cGMP testing. The role may also involve interaction with external clients. This is a full-time position operating Monday through Friday, unless otherwise stated by the Supervisor. Scientific staff may be expected to work overtime, including weekends. Off-site meetings with clients and regulatory agencies are usual occurrences.

Requirements

At least 4 years of industry experience in a QC or Analytical lab with a bachelor's degree, preferably in Biochemistry, Chemistry, Biology, or Pharmaceutical Sciences.
At least 2 years of industry experience in a QC or Analytical lab with a master's degree.
Experience with analytical testing and equipment using analytical biochemistry methods.
Experience writing reports, procedures, and specifications.
Knowledge of GMPs and regulatory audits.
Experience with potency/ELISA and/or HPLC is essential; experience in either HPLC/CE or potency/ELISA assay methodologies is required.
Experience with most, if not all, of protein characterization, electrophoresis, chromatography, and assay validation/qualification.
Strong written and verbal communication skills, multitasking ability, attention to detail, and relationship-building skills.
Ability to perform activities involving sitting, standing, walking, and occasionally lifting objects up to 20 pounds.
Visual acuity including close, distance, and color vision.

Nice To Haves

Experience with Octet, liquid handler, and Maurice.

Responsibilities

Perform and review routine wet chemistry assays, ELISA and cell-based immunoassays, electrophoresis (SDS-PAGE/IEF), and HPLC.
Train or supervise the experimental work of more junior analysts, as needed.
Participate in interdepartmental and technology-transfer teams.
Develop, review, revise, and write test methods, standard operating procedures, and related documents.
Perform trending analysis, as needed.
Serve as study lead for validation projects, investigations, and method-development projects, as designated.
Participate in regulatory inspections.
Support continuous improvement initiatives.
Perform other duties as assigned.
Interface with Quality Control as methods are transferred for cGMP testing and, as applicable, with external clients.