Quality Control Senior Scientist
Sanaria Inc., a Rockville, MD based biotechnology company, is seeking a Senior Quality Control Scientist for a unique and challenging opportunity on a world-class team working on the development and commercial manufacturing of a live sporozoite-based malaria vaccine that provides effective long-term immunity and lays the groundwork for eradication of malaria in areas where it is endemic. This position will lead QC efforts as the company moves to Phase III clinical trials.
Sanaria’s vaccine production is based on the life cycle of the parasite. Sanaria is producing material intended for Phase 3 trials and launch. Sanaria’s manufacturing is a team-based.
The QC Senior Scientist will lead and execute the establishment, qualification and performance of Sanaria vaccine products quality control (QC) cell-based assays for product release, stability testing, method qualification and validation compliant to FDA and EMEA CGMP regulations. This position will also serve as the subject matter expert on in-vitro hepatocyte assays to evaluate the potency and attenuation assay of Sanaria’s PfSPZ-based products for clinical and for commercial use. The incumbent is responsible for routine cGMP testing and record keeping, assay optimization, qualification and investigation of QC release and stability assays.
Essential Duties and Responsibilities:
- Oversee, conduct and manage routine operations of hepatocyte culture lab in support of GMP testing for release and stability assays, and hepatocyte assays in support of grant-related research activities.
- Independently plan and perform CGMP and research in-vitro hepatocyte potency and attenuation assays in support of release, stability and research testing.
- Perform microscopic identification and enumeration of transformed sporozoites within hepatocytes using phase contrast and epifluorescent microscopes for potency and safety testing of PfSPZ final product(s) release and stability, and towards fulfilling specific goals of research grants.
- Document testing and results in compliance with CGMP regulations mandated by FDA and Sanaria SOPs.
- Work on method development and execute assays on QC method optimization and troubleshooting, including identification of better cells for assays and research in rodent and simian model malarias.
- Work with Quality team to plan and execute method validation protocols.
- Work with Quality team to plan and execute investigations and CAPA plan.
- Train and qualify operators on cell culture and culture maintenance.
- Train and qualify operators on microscopic readouts for potency and attenuation assays.
- Perform immunofluorescence assays (IFA) on sporozoites and blood stage malaria parasites on clinical and preclinical samples. Train and qualify other operators on IFA.
- Perform, analyze, and refine assays to assess the impact of antibodies, and potentially cells and cytokine on sporozoite invasion and development in hepatocytes.
- Revise and write QC SOP’s and test records.
- Plan and write Study Protocols and reports.
- Supervise and mentor QC analysts and contractors.
PhD with 2 to 3 years’ or MS (Biology, Biochemistry, Chemistry, Microbiology) with minimum 5 years’ experience in Pharmaceutical industry preferably in vaccine manufacturing and testing. 2 to 3 years’ experience with developing and performing cell based potency assays, viability and enumeration procedures. Proficient in microscopy (light microscope, compound phase contrast microscope) and fluorescent imaging. Proficient in ICH guidelines on bioassay method validation. Familiar with bioassay statistical programs. Minimum 1 to 2 years’ experience in authoring validation protocols and plans. Supervisory experience a plus but not required. Work independently and achieve outstanding results. Strong verbal and written skills. Able to work flexible hours, including hours required to set up hepatocyte cultures on evenings of production campaign days. Able to work proficiently with lab equipment including fluorescent microscopes, incubators, centrifuges, etc.
Please send cover letter, resume and salary history to careers(at)sanaria.com, subject line “QC Senior Scientist”. For more information, please visit www.sanaria.com. Sanaria Inc. is an equal opportunity employer.