PRIMARY OBJECTIVE: Strong understanding and demonstrated expertise with the latest cell therapy analytical technologies, method development/qualification/validation, and GMP Quality Control. Functions will include: the development, qualification and validation of methods for GMP release of cell therapies and vector technologies, the technology transfer of methods to CMOs, establishing and maintaining quality controls to assure method reliability through development and manufacturing. The successful candidate will be responsible for working across functional areas such as research, development, clinical, regulatory, and manufacturing to enable critical decisions across the company portfolio. MAIN ACCOUNTABILITIES: Provide management and accountability for the generation of GMP methods to enable clinical cell and vector manufacturing. Provide senior scientific leadership and set strategic direction of technology advancement. Manage development, qualification, and validation of GMP assays for identity, purity, viability, strength and potency. Lead analytical development team in the development of high-quality product and in-process analytics, ensuring compliance with regulatory guidelines. Review and finalize SOPs, protocols, method validations, stability studies and analytical reports that meet all applicable regulatory requirements. Work closely with research/preclinical teams to identify relevant assays suitable for GMP adaptation for all cell and vector quality attributes. Work closely with process development and protein science teams to deliver analytical results for process decision making and regulatory needs. Work closely with CMO QC and manufacturing teams to ensure assay control in GMP environment. Review and approve sample collection procedures, storage and transmission specifications for GMP protocols, system suitability controls, assay raw material specifications, and all GMP test methods at company and CMOs. Conduct comparability assessment (as needed) for any changes made to qualified/validated assays. Contribute to relevant analytical sections of IND/BLA and other regulatory documents. Strong scientific and operational background in implementation of flow-based assays, molecular biology assays and microbiological safety assays Strong understanding of method validation, sample analysis, GLP, GMP requirements, ICH guidelines and FDA guidance. Interact closely with other company team members to ensure that analytical activities are prioritized appropriately and the deliverables are achieved in a timely manner.
cell culture, CAR T, Mammalian Cell Culture, GLP, GMP, validation, BLA, protein expression, Virus Expression, B Cells, Flow based assays, validating assays, Vaccine, Vector Analysis
Validation BLA Cell Culture Protein Expression Virus Expression
PREFERRED QUALIFICATIONS: PhD in Chemistry, Biochemistry, Pharmacology or Analytical Science with 8 or more years of pharmaceutical industry experience and a demonstrated technical leadership in analytical research and development, or MS/BS with 12+ years of relevant experience. Proven ability to provide analytical expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies. Experience working in a GMP regulated environment. Strong scientific and operational background in the optimization and validation of immunochemical and cell-based assays. Experience managing individual contributors. Strong understanding of method development, technical transfer, and GMP requirements. Experience with IND and/or BLA submissions.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.