Direct the establishment of analytical methods in the Analytical Development (AD) lab.
This individual will be responsible for developing and qualifying/validating analytical methods for viral vectors and transferring these processes from the AD lab to the QC lab in accordance with cGMP standards.
The role requires collaboration with cross-functional teams to establish and implement the best regulatory and laboratory practices and to lead the execution of complex experiments at our Indiana site.
Essential Job Functions:
Develop, optimize, and standardize analytical methods for viral vector characterization, including Lentiviral (LVV), Retroviral (RVV), and Adeno-associated Virus (AAV) vectors.
Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory standards.
Implement best laboratory practices to maintain consistency, accuracy, and reliability of analytical results.
Act as SME for the platform analytical process.
Maintain familiarity with current analytical methods, including ddPCR, Flowcytometry, ELISA, qPCR based assays
Maintain familiarity with current equipment used in Analytics lab
Develop, Qualify/Validate analytical methods to support the cGMP testing
Establish a robust process transfer protocol to move analytical methods from the AD lab to the QC lab and or Client laboratories.
Help train AD/QC associates and technicians and work closely with other departments, assisting in project planning
Analyze regulatory authorities' programs, guidance documents, and activities in areas relevant to testing of biological products
Advise site and quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued
Execute research timelines to meet program and corporate objectives
Deal with abstract and concrete variables in situations where only limited standardization exists
Maintain high quality deliverables and open communication, creating a collaborative working environment
Contribute to a collaborative, creative and rigorous culture of scientific discovery