The Associate Scientist will work within the process development team to execute experiments associated with the development of novel scalable viral vector production platforms for use in gene therapy applications. This position will support process development activities at AavantiBio. These activities will assist the process development team in progressing gene therapy drug candidates from research grade to clinical-grade use.
The candidate will need to review and understand technical documents, batch records for small- and large-scale production, standard operating procedures (SOPs), protocols, etc. related to upstream and downstream processes. Candidate must be able to communicate and write in a scientific manner.
The candidate will be trained to support both upstream and downstream processes. The candidate will learn to prepare and modify documents; including, but not limited to, SOPs, Batch Records, and qualification protocols. They will learn and be expected to maintain equipment and materials in the lab suites. Previous knowledge of aseptic technique, cell culture, protein purification, and Good Documentation Practices (GDP) is preferred. The candidate will execute process development operations and experiments under the direction of experienced team members. Adherence to proper safety and quality procedures is a must.
Essential Job Functions:
· Perform upstream and downstream operations in support of production and development runs for the manufacture of viruses to support process development.
· Ability to execute process development studies, effectively analyze and interpret data, and generate presentations and summary reports to document appropriately.
· Ability to work under pressure in a fast-changing environment, train on and use complex equipment, and learn advanced techniques.
· Ability to make detailed observations, propose improvements, and troubleshoot laboratory protocols and operations.
· Follow detailed protocols, batch records, and SOPs for processes and equipment.
· Contribute to completion of production runs efficiently and safely while adhering to Good Documentation Practices (GDP) and Good Laboratory Practices (GLP)
· Coordinate and organize the use of equipment and materials to maintain optimal operations.
· Maintain lab by properly handling and disposing of waste, cleaning equipment and surfaces, and distributing and organizing materials.
· Perform required calibration, cleaning, and preventative maintenance of equipment, as required.
· Maintain and review material inventory to ensure production readiness.
· Communicate between groups, peers, and leadership daily.
· Other duties as assigned.
· Requires a Bachelor’s of Science Degree in a related field. (Chemical/biochemical engineering, biochemistry, chemistry; or related biological science)
· Process development and/or manufacturing experience preferred.
· Hands-on experience with cell culture, filtration, and purification techniques preferred.
· Experience working in a GLP/GMP environment preferred.
· Excellent writing and verbal skills is a must.
· Ability to work in a dynamic team environment.
The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Full-time salary position with the opportunity for annual bonuses and participation in the Equity Incentive Plan. Benefits include high-quality health insurance plans including both gold and platinum Blue Cross Blue Shield plans, for which AavantiBio pays a competitive 85% of the health insurance premiums for our employees and their families. In addition to health insurance, we have put in place flexible spending accounts and other benefits for our employees, including dental, vision, short- and long-term disability, group life insurance, AFLAC, and more. To assist our employees with their retirement planning, AavantiBio offers a safe-harbor 401(k) plan with a generous 6% company match.
EQUAL OPPORTUNITY EMPLOYER
AavantiBio is committed to nondiscrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.