The Scientist II or III position will support Analytical Development/Quality Control (AD/QC) activities. The Scientist will work with the AD/QC Team to develop and qualify analytical methods in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The Scientist will also perform routine testing in support of 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, Standard Operating Procedures (SOPs), and other documents in accordance with quality standards.
· Assist in the management of analytical method transfer to Good Manufacturing Practice (GMP) testing organizations. As well as the review of test reports, Certificates of Analysis (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 Good Documentation Practices (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 safety culture through programs to identify and address concerns
· Handle and store reagents appropriately and safely.
· Other duties as assigned.
· M.S. degree in an appropriate area of specialization.
· A minimum of four years of appropriate experience in the same or related fields.
· Degree requirement can be lessened by experience.
· At least four 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.
· Excellent communication skills, including technical writing ability.
· 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.
About AavantiBio, Inc.
Biotech company - 15 - 50 employees
AavantiBio is a clinical-stage biopharmaceutical company committed to developing and commercializing novel gene transfer and gene editing therapies for the treatment of rare and ultra-rare genetic diseases. The company is rapidly building a diverse portfolio of gene transfer and gene editing therapies to target debilitating genetic diseases for which the unmet medical need is high and for which there are typically no approved therapies treating the underlying disease.
AavantiBio is headquartered in Cambridge, MA with additional locations in Gainesville, FL. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene transfer therapy.
Developing genetic treatments for rare diseases is inspiring but challenging work and it takes dedication and courage which will make a meaningful impact on those who suffer from rare diseases. At AavantiBio, we will push each other to perform at our very best, and build a company that not only our employees are proud of, but also the rare disease community, because everyone knows we are trying to make a difference in patients’ lives.
Come join our team!
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.