Senior Research Associate, Analytical Development

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 highly motivated and team-oriented Senior Research Associate with strong technical aptitude, to be a member of Analytics team reporting to Senior Director. This is an on-site, lab-based, outstanding opportunity for a candidate to execute Analytical Sciences strategy in a cross-functional collaborative environment supporting development and cGMP manufacturing of cell and gene therapies. The primary assignments encompass routine analytical technical operations, such as executing assay development, optimization, in-process testing, for cell and gene therapy products. Analytical stage-specific additional responsibilities are assigned that require cross-functional assay development or optimization with a goal of seamless integration and transfer of new analytical methods for quality-controlled testing.

This is an exciting opportunity for well-qualified candidates to join a rapidly growing company focused on turning today’s cutting-edge research into tomorrow’s breakthrough therapies. Together with our partners and collaborators, we are effecting broader changes in the healthcare industry and making a positive impact on people’s lives and our society.

Responsibilities

· Execute analytical test methods to support on-site lab-based cell and gene therapy technical operations.

· Analytical platforms for gene, protein and biophysical characterization, include 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 analytical activities, including 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.

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

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

Qualifications

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

· 2+ years of experience working in a biopharmaceutical, ideally with hands-on experience in cell and/or gene therapy.

· 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.

· Familiarity with cGMP requirements is preferred.

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