DescriptionJOB LOCATION: 14191 Myford Road, Tustin, CA 92780
Key Responsibilities:
- (20%) Supervise and train up to 5 direct reports on the scheduling and execution of cell-based bioassays.
- (2.5%) Coordinate filled visual inspection for product lot release.
- (10%) Lead and execute assay qualification, method validation, special studies, investigations, method development and tech transfer projects.
- (10%) Act as Subject Ma er Expert for cell propagation, cell line maintenance, and other tasks related to cell-based assays.
- (10%) Perform and review routine assays for Cell Based Assay, either thaw and go or with cell propagation, with strict adherence to written analytical test procedures.
- (2.5%) Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
- (10%) Provide guidance to Analysts and Sr. Analysts regarding lab work.
- (7.5%) Review, revise and write test methods, standard opera ng procedures and perform trending analysis as needed.
- (2.5%) Write study protocols and reports.
- (5%) Collaborate with other departments in developing, revising and implementing QC procedures and policies.
- (5%) Stay abreast of company cGMPs as well as industry regulations that apply to all job functions.
- (5%) Participate in regulatory inspections.
- (10%) Actively participate in departmental continuous improvement efforts and perform other du es as assigned.
REQUIREMENTS: Education/ Experience Requirements: Position requires a Master's degree in Biology, Biochemistry, or Chemistry and 3 years of experience as a Scientist/Research Scientist, or Research Associate, or a Bachelor's degree in Biology, Biochemistry, or Chemistry followed by 5 years of experience as a Scientist/Research Scientist, or Research Associate.
Experience must also include 3 years of experience with each of the following:
1. Experience in a QC or analytical lab setting.
2. Analytical testing and equipment, writing reports/procedures/specifications, and supporting QC audits.
3. Maintenance and propagation of cell lines, execution of cell-based assays.
4. Experience with cell-based potency assays including luminescence and fluorescence or colorimetric detection systems.
5. Handling suspension and adherent or primary/immortalized mammalian cell lines to develop growth conditions to support cell-based assay development.
6. Electrophoresis (SDS-PAGE, Western Blot, and DNA agarose gels), ELISA plate-based assays, quantitative PCR, and aseptic handling techniques.
7. Performing cell-based assay optimization and validation.
Position Type/Expected Hours of Work:This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.
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 $152,776 - $153,776 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 25 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.
