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Develop and review wet chemistry, ELISA, cell-based immunoassay, electrophoresis, and HPLC methods for protein biologics. Write and revise methods, SOPs, reports, and specifications; support assay validation, investigations, trending, regulatory inspections, method transfers, and continuous improvement. May lead validation and method-development studies, train junior analysts, supervise experimental work, and collaborate with Quality Control, process development teams, clients, and regulatory agencies.
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:
Are you an experienced Sr. Research Associate, Analytical Development looking to take the next step in your career? We're seeking a talented and passionate individual to join our Analytical Development team as we develop cutting-edge protein biologics. As our Sr. Research Associate, you'll have the opportunity to focus on developing Cell-based, ELISA, HPLC, CE, PCR and/or SDS-PAGE methods, and you'll work alongside experienced analytical scientists and process development scientists to identify and characterize protein biologics. This position offers the chance to interface with our Quality Control testing group as methods are transferred into that group for cGMP testing, and you may also have the opportunity to interface with external clients. Don't miss out on this exciting opportunity to join a team that's making a difference in the world of biologics. Apply now and take your career to the next level!
Key Responsibilities:
- Perform and review routine wet chemistry assays and ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF) and HPLC.
- May train/supervise the experimental work of more junior analysts and may be a member of interdepartmental/tech transfer teams.
- Develop, review, revise and write test methods, standard operating procedures and may perform trending analysis.
- May be designated as study lead for validation projects, investigations, and method development projects.
- Previous experience in either HPLC/CE or Potency/ELISA assay methodologies is required.
- Knowledgeable of company cGMPs as well as industry regulations that apply to job functions. Participates in regulatory inspections.
- Support continuous improvement initiatives.
- Other duties as assigned.
Minimum Qualifications:
- 4+ years industry experience working in a QC or Analytical lab (with a BS degree) preferably Biochemistry, Chemistry, Biology or pharmaceutical sciences
- 2+ years industry experience working in a QC or Analytical lab (with a MS degree)
- Analytical testing and equipment utilizing analytical biochemistry methods
- Writing reports/procedures/specifications
- GMPs and regulatory audits
- Potency/ELISA and/or HPLC experience is essential.
- Should also have experience with most, if not all the following: protein characterization, electrophoresis, chromatography, and assay validation/qualification.
Preferred Qualifications:
- Experience with Octet, liquid handler and Maurice is a plus!
Position Type/Expected Hours of Work:
This role is a full-time position operating Monday through Friday, unless otherwise stated by Supervisor. Any scientific staff member can expect to work overtime, including during the weekends. Off-site meetings with clients and regulatory agencies are a usual occurrence.
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 $84,000 - $105,000 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.
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