Perform aseptic cell culture development activities for recombinant protein vaccine antigens that will be directly used for clinical and commercial vaccine candidate manufacturing processes. Responsible for developing early and late stage of cell culture and upstream platform production processes for novel viral vaccine candidate molecules. Streamline antigen development workflows related to clone selection, cell banking and pre-GMP cell bank testing, early process development and tech transfer. Conduct bioanalytical assays to characterize and quantify vaccine antigens and contaminants. Operate or develop products to use in bioreactor systems (AMBR250 and wave and stirred tank bioreactors). Follow current Good Manufacturing Practices and regulatory requirements for filing and registration of vaccine and/or biologic products. Aid in the execution of analytical methods and support the purification development for viral vaccines. Author technical reports, experimental protocols, and technical summaries for presentation as well as participation in the technology transfer of processes into cGMP production facilities. Direct selective efforts for cell line engineering and optimization including but not limited to building a comprehensive genome editing/characterization toolbox. Interface with in-process analytical and analytical development to support robust early process and product characterization. Actively collaborative with other global business units, participate in TDT and CMC discussions to meet accelerated project timelines. Presenting project updates/ scientific/technical findings at internal and external meeting/conferences. Ensure that work is conducted in a safe and compliant manner; maintain lab documentation and practice in accordance with established SOPs, GLP and GCP regulation. Performing mammalian platform based pre-GMP cell line development activities and co-authoring Drug substance CMC section for regulatory filings (cell line derivation report and raw material risk assessment). Utilize cell culture and viral vector production processes related instrumentation, including automated bench-top bioreactor (AMBR15/250 and 3L Bioreactor) as well as PAT technologies (Vicell, Cedex Bio HT analyzer, Nova Bioprofile 400, or Metaflex). Perform CMC early-stage upstream process development workflow. Plan, execute and perform data analysis using Design of Experiments (DoE) and Multivariate analysis (MVA). Implement advanced high throughput bioanalytical assays for early product characterization of vaccine candidates. Engage in functional cross-training with an interdisciplinary team of professional scientists, including virologists, cell and molecular biologists, to facilitate protein characterization using high-resolution mass spectrometry techniques, such as Liquid Chromatography and Mass Spectrometry (LC-MS). Lead the preparation of formal technical reports and publications to advance patent, regulatory and IND filings, thus enabling the organization to transition from the pre-clinical to clinical stages of drug discovery. Lead clone development projects, Master Cell Bank generation and supervise other more junior staff in this activity, and be accountable for experiment planning activities, clinical processes, and analysis throughout the vaccine development cycle.Basic Qualifications
Must have a Master's degree (or foreign equivalent) in Biology, Cellular & Microbial Biology, or a related field and 4 years of experience in 1) Mammalian platform based pre-GMP cell line development activities and co-authoring Drug substance CMC section for regulatory filings (cell line derivation report and raw material risk assessment); 2) Cell culture and viral vector production processes related instrumentation, including automated bench-top bioreactor (AMBR15/250 and 3L Bioreactor) as well as PAT technologies (Vicell, Cedex Bio HT analyzer, Nova Bioprofile 400, or Metaflex); 3) CMC early-stage upstream process development workflow; 4) Planning, executing and performing data analysis using Design of Experiments (DoE) and Multivariate analysis (MVA); and 5) Implementing advanced high throughput bioanalytical assays for early product characterization of vaccine candidates. Employer will also accept a Bachelor's degree (or foreign equivalent) in Biology, Cellular & Microbial Biology, or a related field and 6 years of post-baccalaureate, progressively responsible experience in the above.Preferred Qualifications: None
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