Senior Quality Control Specialist
Senior Quality Control Specialist Sanaria is seeking a Senior Quality Control (QC) Specialist for a unique and challenging opportunity working on the development and commercial manufacturing of a unique malaria vaccine. Sanaria’s vaccine production is based on the life cycle of the most important malaria parasite, Plasmodium falciparum (Pf), and its vaccine candidates are all composed of the mosquito salivary gland stage of the parasite, the sporozoite (SPZ). Sanaria has developed a unique process that results in PfSPZ being manufactured under cGMPs as a pipeline of vaccines showing high efficacy in a series of clinical studies.
Sanaria is now producing material intended for Phase 3 trials and launch. An important element in the release and stability of the PfSPZ products is a set of cell-based assays that replicate in vitro the invasion of the liver by SPZ (hepatocyte assays) by detecting SPZ that have invaded into and developed in hepatocytes. This requires excellent skills in cell culture and fluorescence microscopy, along with a close attention to detail and adherence to GMPs. The Senior Quality Control Specialist will perform cell-based QC assays for the release and stability testing of Sanaria’s PfSPZ products incompliance with 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 Senior QC Specialist will serve as a key member of the Quality Team for release of GMP materials in coordination with the Materials Management Department.
Essential Duties and Responsibilities:
- Conduct and assist in managing routine operations of a hepatocyte culture laboratory in support of GMP testing for release and stability assays, and hepatocyte assays in support of grant-related research activities. •Independently plan and execute in vitro hepatocyte potency and attenuation assays in support of GMP release and stability, and of research: this includes a timeline that matches the manufacturing schedules and research project outputs.
- Identify and enumerate by phase contrast and fluorescent microscopy liver stage parasites within hepatocytes 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 cGMPs mandated by FDA guidelines and Sanaria SOPs. •Work on method development, optimization and troubleshooting, including identification of better cells for assays and research in rodent and simian malaria models. •Work with Quality team to plan and execute method validation protocols.
- Train and qualify operators on cell culture. •Train and qualify operators on microscopy 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 cytokines on SPZ invasion and development in hepatocytes.
- Assist with writing and revision of QC SOP’s and test records.
- Perform GMP materials release in coordination with the Materials Management Department.
Education and experience:
- MS (Biology, Biochemistry, Chemistry, Microbiology) with minimum 3 years’ experience in the Pharmaceutical industry, preferably in vaccine manufacturing and testing.
- Two to 3 years’ experience developing and performing cell based assays, and viability and enumeration procedures.
- Highly proficient in microscopy (phase contrast microscopy, fluorescence microscopy), and proficient in imaging and image analysis.
- Knowledgeable aout ICH guidelines for bioassay method validation. Familiar with statistical analysis of bioassays, and able to describe data trends and identify outliers.
- Able to work independently and achieve outstanding results, and must have strong verbal and written communication skills.
- Able to work flexible hours, including hours required to set up hepatocyte cultures on evenings or weekends. Able to work proficiently with lab equipment including fluorescence microscopes, incubators, centrifuges, etc.
Please send cover letter, resume and salary history to firstname.lastname@example.org, subject line “Senior QC Specialist”. For more information, please visit www.sanaria.com. Sanaria Inc. is an equal opportunity employer.