QC Associate - Analytical Sciences, Technical Operations, Cell and Gene Therapy

QC Associate - Analytical Sciences, Technical Operations, Cell and Gene Therapy

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