The Scientist I position will support the Analytical Development/Quality Control (AD/QC) activities. The Scientist I will work with the AD/QC Supervisor/Manager to develop and qualify analytical methods in accordance with ICH guidelines. The Scientist I will also perform routine testing in support of the process development and product characterization activities.
· 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.
· Develop, optimize, and qualify analytical methods in accordance with ICH guidelines.
· Write and review development reports, test methods, SOPs, and other documents in accordance with quality standards.
· Support analytical method transfer to GMP testing organizations. As well as the review of test reports, COAs, and other documentation from those organizations.
· Assist with routine testing of analytical methods internally to support process development activities.
· Effectively communicate results both verbal and written to guide decision-making.
· Enforce and follow GDP in records and logbooks.
· Write deviations, event investigations, corrective and preventive actions as needed.
· Enforce and follow Good Laboratory Practices (GLP).
· Work to develop and maintain our safety culture through programs to identify and address concerns
· Handle and store reagents appropriately and safely.
· Other duties as assigned.
· B.S. degree in an appropriate area of specialization and two years of appropriate experience in cell or gene therapy. Degree requirements can be lessened by experience
· Excellent communication skills, including technical writing ability
· Strong attention to detail and organizational skills
· Ability to work in a team
· At least two years of experience in a QC and/or AD environment
· Ability to develop new analytical methods in accordance with ICH guidelines
· Previous assay validation experience
· Previous experience with ddPCR, qPCR, ELISAs, and cell-based assays.
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.
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.