THIS IS A CONTRACT POSITION FOR 6 MONTHS
We are recruiting a highly motivated QC Associate to perform laboratory testing within a fast-paced GMP environment. This is an outstanding opportunity for a candidate to work under the guidance of a supervisor and mentor, manage time effectively, complete assigned analytical tasks in a cross-functional collaborative environment supporting development and cGMP manufacturing of cell and gene therapies.
Scope of Responsibilities
· Complete required read/understand courses, bench-work training and quality-controlled cGMP documentation requirements.
· Execute assigned analytical test methods, with cGMP compliance, to support cell therapy manufacturing, vector manufacturing, and fill finish.
· Support analytical assay development ensuring they are robust enough for qualification, transition to quality control and successful implementation.
· Perform general laboratory tasks, including maintenance and troubleshooting of equipment.
· Maintain accurate and reliable records, electronic lab notebook entries, and all other pertinent documentation.
· Comply with all environmental health and safety standards.
· This is a hands-on lab-based position requiring flexibility based on cell & gene therapy drug product manufacturing schedule.
Minimum Qualification
· Bachelor’s or Master’s degree in science, biology, chemistry or a related field (graduate degree or certifications and continuing education a plus).
· Ability to manage and prioritize tasks and projects, with the guidance of management.
· Strong verbal and written communication skills.
Preferred Qualifications
· QC Analyst I: Bachelors with minimum of 2 years or Masters with minimum of 1 year of relevant work experience, preferably in a cGMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy.
· Demonstrate experience in at least one protein- and one genome-based techniques (e.g. nanoparticle characterization, gel electrophoresis, western blotting, capillary electrophoresis, flow/nanoflow cytometry, ELISA and qualitative/quantitative PCR (qPCR, dPCR, ddPCR) or appropriate work experience in aseptic mammalian cell culture.
· Demonstrate working knowledge of cGMP requirements.
· Strong leadership skills, with an excitement to both roll up your sleeves and be a thoughtful partner