Quality Control Flow Cytometry
Job Description
- Conducting and coordinating technology/method transfer of new and existing methods from internal and external laboratories.
- Lead method qualifications and validations of established assays.
- Take part in the stability testing of our clients products as well as in-process and finished product associated with our client’s clinical trial material.
Qualifications
- BS or MS in molecular biology, biomedical sciences or related specialties required
- At least three years working in a GMP quality control laboratory; 5+ years experience preferred
- Knowledge of GMP regulations including USP and EP testing
- Experience conducting technology transfers of new methods
- Experience developing flow cytometry panels
- Experience with flow cytometry panel assay development
- Experience with flow cytometry compensation, instrument standardization, assay optimization and troubleshooting
- Direct experience validating flow cytometry assays for a GMP laboratory
- Experience with plate based flow cytometry assays
- Familiarity with the BLA submission process
- Technical writing skills for drafting equipment and laboratory standard operating procedures
- Experience conducting qualifications and/or validations of analytical methods
- Ability to prepare data trending reports, and to author, review and maintain test methods, qualification protocols, SOPs and reports
- Conduct laboratory investigations and of prepare deviations and CAPAs as needed
- Ability to identify and implement continuous improvement projects for lab process efficiencies
- Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
- Ability to work on assigned projects independently with limited supervision
- Ability to track and trend assay and equipment data
Additional information
Position is full-time, first shift, Monday - Friday 8:00am - 5:00pm Candidates currently living within a commutable distance of Philadelphia, PA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.