Adaptive Phage Therapeutics (APT) is a clinical-stage biotech advancing therapies to treat multi-drug resistant infections. We are on a mission to address today’s — and tomorrow’s — toughest infections. We are looking for intelligent and motivated people to help us reach those goals.
The QC Analyst will participate in the performance of testing of APT products under cGMP conditions in the Quality Control laboratories. Testing methodologies include maintenance of microbial cultures, viral infectivity assays, ELISA, PCR, particle sizing, endotoxin (LAL), environmental sampling of controlled ISO 5-8 classified areas and traditional wet chemistry methods. Testing activities include routine lot release and stability testing, as well as qualification/validation of analytical methods.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Perform raw material, in-process, release, and stability testing for APT products under cGMP conditions.
Perform sample management activities, e.g. receipt/log-in, storage, and retrieval for samples submitted to Quality Control.
Perform environmental sampling for routine environmental monitoring (EM) of cleanrooms.
Maintain EM equipment with cleaning and preventive maintenance, as required.
Maintain required QC records and logs via paper and computerized systems.
Perform preparation and shipment of samples to external contract testing laboratories.
Report and participate in the investigation of QC related deviations, out-of-specification results, and EM excursions.
Write technical documents such as reports, change controls, and SOPs.
Participate in testing for analytical method qualification/validation.
Maintain the QC laboratory and equipment in a clean and organized state.
Other duties as assigned.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required for this job. Duties, responsibilities, & activities may change at any time with or without notice.
Bachelor of Science degree/equivalent in life sciences or related field.
3-5 years of experience in pharmaceutical or biotechnology Quality Control.
Experience with viral plaque assays is a plus.
Working knowledge of cGMP regulations.
Fluency with commonly used Microsoft software applications (MS Word, MS Excel, MS PowerPoint, SharePoint).
Full COVID-19 vaccination required; APT employees are required to be fully vaccinated against COVID-19 to work on the premises.
Microbial cell culture and aseptic technique under BSL-2 conditions.
Understanding of cGMP compliance in the Quality Control laboratory.
High level of attention to detail.
Ability to manage multiple and varied tasks and prioritize workload.
Flexibility and adaptability to adjust to changing priorities and unforeseen events.
Excellent time management skills.
Ability to work in a fast-paced environment with little supervision.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job and will be available to the candidate upon request.
APT is an Equal Opportunity/Affirmative Action employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. APT seeks to diversify its work force and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.