QC Analyst II, second shift

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.

We are seeking a QC Analyst II to join the second shift (2pm – 10pm) integrated Analytics team, reporting to the Senior Director, Analytics.  This role supports our goal of seamless integration, transfer and execution of new analytical methods for QC testing.

Responsibilities

·       Execute analytical test methods in accordance with cGMP regulations in support of cell therapy, vector, and fill finish manufacturing.

·       Support all aspects of routine QC Bioanalytic activities, including the QC testing schedule, test sample handling, equipment calibration and preventive maintenance activities.

·       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, ensuring data integrity and adhering to Good Documentation Practices.

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

·       Flexibility to work occasional off shift hours/weekends as needed.

·       Additional job responsibilities as agreed with the manager.

Qualifications

·       Bachelor’s/Master’s degree in science, biology, chemistry, or related field, or equivalent.

·       Min 2 years of experience working in a cGMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy, including with analytical platforms for gene, protein and biophysical characterization, such as PCR (qPCR and ddPCR), flow cytometry, plate reader-based assays (ELISAs) and assays with different end-point chemistries, particle counters, molecular biology including gel electrophoresis, western blotting, HPLC.

·       Preferred experience in multiple analytical technologies, aspects of aseptic mammalian cell culture, cell enumeration, viability estimation and phenotypic characterization.

·       Strong working knowledge of cGMP requirements.

·       Strong leadership skills, able to manage and prioritize tasks and projects with management oversight.

·       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.