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Sr. Analyst (ELISA), Quality Control
Avid BioservicesUnited Statesfull_timeVerifiedPosted 20 Mar 2025
💰 $87,700/yr($65,800/yr – $87,700/yr)
About the role
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: Looking for an exciting opportunity to utilize your expertise in ELISA/cell-based immunoassays and electrophoresis in a fast-paced GMP environment? We are currently seeking a skilled Sr. Analyst, Quality Control to join our team! In this role, you will be responsible for performing critical testing and sampling to support manufacturing, validation, process development, and stability studies. Additionally, you will have the opportunity to lead and support continuous improvement initiatives, ensuring that our processes and procedures are always up to the highest standards.
- Perform and review routine assays for ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF), and polymerase chain reaction (PCR) testing with strict adherence to written analytical test procedures and good documentation practices following the ALCOA system in a GMP environment.
- Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
- Review, revise and write test methods, standard operating procedures and may perform trending analysis. In addition to performing QC testing, the Analyst may be designated as study Lead for validation projects, investigations, and method development projects.
- Other functions include, but are not limited to, writing study protocols and reports; training other analysts; working with other departments in developing, revising and implementing QC procedures and policies, ordering supplies and reagents for tests, and formulating buffer
- Knowledgeable of company cGMPs as well as industry regulations that apply to all job functions.
- Participate in regulatory inspections.
- Support continuous improvement initiatives.
- Other tasks as assigned.
- B.S. in chemistry, biology, or related field.
- 3+ years industry experience in a QC or analytical lab, or equivalent combination of education/experience.
- Experience with analytical testing and equipment, writing reports, procedures, specifications, GMPs and regulatory audits are essential.
- Strong ELISA, Analytical Biochemistry and Chemistry experience.
- Experience with most, if not all the following: protein characterization, electrophoresis, chromatography (normal phase, reverse phase, size exclusion, ion exchange, etc.), aseptic techniques, assay, and validation/qualification.
- Experience working in a cGMP lab.
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
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