Scientist I, Analytical Development

Job Summary

Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab from the bench. This is a hands on position that requires technical expertise and ability to design and execute experiments for the biophysical characterization of viral vector particles. This individual will be accountable for development and validation of analytical and QC assays, equipment specification and selection. The incumbent will also be responsible for analytical method from the analytical development lab to the QC lab while operating under cGMP standards under guidance from department head and QC/QCTS leadership. The person is expected to work collaboratively with the team to establish and implement best regulatory, laboratory practices and to lead the execution of complex experiments. The position requires expertise in the biophysical characterization of AAV particles with an emphasis on HPLC based methodology using various detectors including UV-Vis, CAD, and MALS detectors. Experience using Astra software for SEC-MALS analysis is required

Job Responsibilities

• Expert in HPLC based methodology development and establishment including with the use of CAD and MALS detectors for use in the characterization of AAV vectors.
• Expected to be able to operate HPLC associated equipment including equipment troubleshooting as required.
• Extensive experience with the use of ASTRA software.
• Familiarity with OpenLab software for the analysis of HPLC based readouts.
• Maintain familiarity with other current analytical and bioassay methods, including Flowcytometry, ELISA, qPCR and ddPCR based assays in Lenti, Retro and AAV platforms.
• Maintain familiarity with current equipment used in Analytics lab.
• Help management evaluate new technology and bring new platforms in-house.
• Qualify/Validate analytical methods to support cGMP testing.
• Help facilitate tech transfer of analytical and bioassays from clients to AD lab and from AD lab to QC lab.
• Assist with training AD Associates and other team members where needed and work closely with other departments, assisting in project planning
• Support the establishment of electronic record keeping systems for site; e.g. LIMS or ELN
• Work as a team with process development, manufacturing, quality assurance and quality control departments as needed
• 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
• 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 collaborative, creative and rigorous culture of scientific discovery
• Provide weekly reports to department head in 1:1 environment

Special Job Requirements

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

Knowledge, Skills and Experience

EDUCATION / CERTIFICATIONS / LICENSES

• BS in scientific/technical discipline (Essential)

ON-THE-JOB EXPERIENCE

• 2-4 years of CRO/CDMO experience in design, development and execution of bioanalytical methods (i.e. method development, qualification, validation and transfer) (Essential)
• Direct hands on experience with MALS and CAD detectors in AAV analytics (Essential)
• Expertise in the biophysical characterization of AAV particles and associated impurities. (Essential)
• Experience with LC-MS based assay development. (Essential)
• Experience with documentation and reporting of results using electronic lab notebooks (Essential)

SKILLS / ABILITIES

• People training and leadership skills (Essential)
• Ability to maintain multiple projects and timelines (Essential)
• Excellent verbal and written communication skills (Essential)
• Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills (Essential)