QC Analyst II

Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation. A public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health.

We are seeking a highly motivated and team-oriented professional with entrepreneurial spirit to join our company! This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today’s cutting-edge research into tomorrow’s breakthrough therapies.

Scope of Responsibilities and Desirable Experiences

· Execute analytical test methods with cGMP compliance, to support cell therapy manufacturing, vector manufacturing, and fill finish.

· QC analytical testing include critical quality attributes for identity, purity, safety, and potency testing.

· Analytical platforms for gene, protein and biophysical characterization, such as PCR (qPCR and ddPCR), flow cytometry, plate reader-based assays including ELISAs and assays with different end-point chemistries, particle counters, molecular biology including gel electrophoresis, western blotting, and HPLC, are utilized during routing testing. Experiences in multiple analytical technologies, and aspects of aseptic mammalian cell culture, cell enumeration, viability estimation and phenotypic characterization are desirable

· Support all aspects of the day-to-day QC Bioanalytic activities, including the QC testing schedule, test sample handling, equipment calibration and preventive maintenance activities, to ensure on-time manufacturing production with cGMP compliance.

· Participate in assay design, development, optimization, training, transfer, verification and qualification protocols.

· Support oversight of testing that may occur at external contract testing laboratories.

· Ensure compliance with cGMP regulations, guidance and industry standards.

· Participate in QC investigations, change controls, and other quality records.

· Author and approve technical protocols and reports, such as analytical procedures and qualification reports. Document analytical methods in electronic lab notebook.

· Meet performance objectives and contribute to a culture of continuous improvement.

· Partner and collaborate with other stakeholders, including Manufacturing, Process Development, Stability, Supply Chain and Quality Assurance, to ensure effective right first-time performance.

Qualification

· Bachelor’s or Master’s degree in science, biology, chemistry or a related field (graduate degree or certifications and continuing education a plus).

· 2-5 years of experience working in a cGMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy.

· Strong working knowledge of cGMP requirements.

· Strong leadership skills, with an excitement to both roll up your sleeves and be a thoughtful partner.

· Ability to manage and prioritize tasks and projects, with the guidance of management.

· Strong verbal and written communication skills.

Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.