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

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

Landmark Bio is dedicated to translating cutting-edge research into life-changing therapies. The company provides CMC development and GMP manufacturing capabilities for cell and gene therapies and other novel modalities, and partners with academic, biotech, and industry collaborators to advance next-generation manufacturing technologies.