Lead, Cell-Based QC Assays & Validation

avidbio; Tustin (CA); On-site; USD 152,776 - 153,776; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in California is seeking a skilled scientist to supervise a small team and lead cell‑based bioassay programs in a QC‑driven environment. The role requires hands‑on experience with assay development, method validation, and regulatory alignment.

The candidate will oversee documentation, SOPs, and test method reviews while coordinating cross‑department QC procedures and participating in inspections. A strong background in cell culture and analytical techniques is essential.

Qualifications

• Master’s degree in Biology, Biochemistry, or Chemistry with 3+ years of related Scientist/Research Scientist experience or a Bachelor’s degree with 5+ years of experience.
• Experience in a QC or analytical lab setting.
• Analytical testing and equipment, writing reports/procedures/specifications, and supporting QC audits.
• Maintenance and propagation of cell lines, execution of cell-based assays.
• Experience with cell-based potency assays including luminescence, fluorescence or colorimetric detection systems.
• Handling of suspension and adherent or primary/immortalized mammalian cell lines to develop growth conditions for assays.
• Electrophoresis (SDS-PAGE, Western Blot, DNA agarose gels), ELISA plate-based assays, quantitative PCR, and aseptic handling techniques.
• Performing cell-based assay optimization and validation.

Responsibilities

• Supervise and train up to 5 direct reports on scheduling and execution of cell-based bioassays.
• Coordinate filled visual inspection for product lot release.
• Lead and execute assay qualification, method validation, special studies, investigations, method development and tech transfer projects.
• Act as Subject Matter Expert for cell propagation, cell line maintenance, and related tasks.
• Perform and review routine assays for Cell Based Assay, including thaw-and-go or with cell propagation.
• Perform aseptic sampling, visual inspection, gowning and work in clean room areas.
• Provide guidance to Analysts and Senior Analysts regarding laboratory work.
• Review, revise and write test methods, SOPs and trend analyses.
• Write study protocols and reports.
• Collaborate with other departments to develop QC procedures and policies.
• Stay abreast of cGMPs and industry regulations; participate in regulatory inspections.

Skills

Team player

Excellent communication

Multitasking

Attention to detail

Relationship building

Cell-based assay development

Education

Master’s degree in Biology/Biochemistry/Chemistry

Bachelor’s degree in Biology/Biochemistry/Chemistry

Tools

SDS-PAGE

Western Blot

ELISA

qPCR

Cell culture

Cell propagation

Job description

Avid Bioservices in California is seeking a skilled scientist to supervise a small team and lead cell‑based bioassay programs in a QC‑driven environment. The role requires hands‑on experience with assay development, method validation, and regulatory alignment.

The candidate will oversee documentation, SOPs, and test method reviews while coordinating cross‑department QC procedures and participating in inspections. A strong background in cell culture and analytical techniques is essential.