Job Title: Analytical Development Scientist
Job Location: Fishers IN 46256
Job Description:
- 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
- Provide monthly reports to department head
