Azzur Lab is looking for a highly motivated Flow Cytometry Scientist I – Quality Control & Analytical Development (QC & AD) to make a difference by the work he/she does in the cell and gene therapy field and other therapeutics. This is a new exciting position in a new lab within an established company as we expand lab functions and capabilities.
Duties and Responsibilities:
The Flow Cytometry Scientist I performs daily lab operations such as QC testing, tech transfer, method development, and equipment maintenance but not limited to the following tasks :
- Method tech transfer either from our clients to our lab or vice versa.
- Reagent qualification.
- Method development including development, optimization, qualification, and validation per the ICH guidelines.
- QC testing including sample management, sample preparation, test execution, data analysis, data reporting, CoA preparation, and data verification when needed.
- Draft SOPs, test methods, protocols, and reports.
- Assist in ordering lab reagents, buffer, and other consumables.
- Keep lab notebook or ELN up-to-date.
- Trouble-shoot and maintain equipment, such as calibration, monthly cleaning, or schedule PM dates with BD… etc.
- Train analysts on analytical method testing and instrumentation as needed.
- Present experimental results and findings in lab meetings.
- Assist QA in performing and managing deviation and OOS investigations, corrective and preventive action plans (CAPA), and change controls.
- Collaborate seamlessly and timely with internal and external stakeholders to support the associated lab functions of the entire assignment or project.
Qualifications and preferred experience:
- Possesses a bachelor’s degree in life sciences or higher.
- 2-5 years of flow cytometry experience in the industry setting, preferably in a QC lab environment.
- Familiar with flow cytometry applications to cell and gene therapy product development.
- Experience with multi-color flow detection assays and cell-based potency assays for lot-release and characterization purposes.
- Well-versed in operating flow cytometers and using 3rd party flow analysis software.
- Knowledge of GCP, GDP, ICH, and 21 CFR part 11 regulations relevant to a clinical QC lab operation.
- A bonus to have experience in sterile cell culture, immunoassays, and molecular detection techniques.
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
- Ensures activities are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader.
- Curious and adaptable - has the ability to transform knowledge into actionable activities.
- Able to produce results in a fast paced, collaborative environment.
Perks of Working at Azzur:
- Medical, Dental and Vision
- Competitive 401K plan
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.
No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with our customers.
Do What You Love
We are seeking highly motivated individuals that have the desire to learn, are able to adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the projects while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for each individual through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.
If a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you!