Sr. Analyst (ELISA), Quality Control
Description
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.
Minimum Qualifications:
- 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.
Preferred Qualifications:
- Experience working in a cGMP lab.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. Must be available to work extended hours if needed.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $65,800 to $87,700 annually, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- 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.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.