The Downstream Scientist I/II – Gene Therapy will work on a team with the goal of driving innovation in the development of novel scalable viral vector production platforms for use in gene therapy applications. The Downstream Scientist position will support development and operations activities at AavantiBio to produce methodologies and material from research grade to clinical-grade use. The candidate will be expected to work with their manager to trouble-shoot technical problems. They will write and review batch records for small- and large-scale productions while ensuring to document and review discrepancies, investigations, etc. related to downstream processes. The candidate will be expected to prepare and modify any document type related to production; including SOPs, PBRs, qualification protocols, etc. They are expected to maintain the equipment in the downstream lab suites. They will also work closely with internal and external groups to achieve production goals and maintain timelines.
· 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.
- Design and optimize downstream processes for the manufacture of viruses for GLP toxicology and early phase GMP clinical manufacturing.
- Ability to conceptualize and execute downstream development studies and effectively analyze and interpret data generated in presentations and summary reports.
- Effective communication of results by both verbal and written media to guide decision-making processes.
- Hands-on experience in purification and filtration techniques of viruses.
- Proficient in use and method design on AKTA chromatography skids.
- Ability to make detailed observations, propose improvements, and troubleshoot experimental protocols.
- Lead junior staff on the downstream process.
- Write and follow detailed protocols, batch records, and SOPs for processes and equipment.
- Complete production runs in an efficient and safe manner 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.
- Source, procure, and/or prepare materials and equipment to successfully complete downstream processes.
- Write Deviations and Investigation Reports
- Review records, SOPs, protocols, etc. for completion and improvement.
- Assist in technical transfer of processes from development to manufacturing.
- · 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 on daily basis.
· Other duties as assigned.
- Bachelor’s Degree in a related field. (Chemical/biochemical engineering, biochemistry, chemistry; or related biological science)
- Proficiency in downstream processing methods (chromatography, TFF, ultracentrifugation, detergent treatment, viral reduction filtration, etc.)
- 2+ years of experience in a downstream lab.
- 2+ years of AKTA software experience
- 1+ year in process development and/or manufacturing of viral vectors.
- Experience in a cGMP environment preferred.
- Excellent writing and verbal skills.
- Ability to work in a team.
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 that are required of an employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
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.