QC Analytics Scientist, 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 highly motivated and team-oriented Scientist, with Quality Control Bioanalytics focus, to join our 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

·       Independently execute QC technical operations using different analytical platforms for a variety of in-process, release and stability testing for novel viral (AAV or Lentivirus) and non-viral cell and gene therapies.

·       Develop, draft, execute, and optimize analytical method qualification protocols, test methods, work instructions, standard operating procedures, and reports in support of new assay implementation and transfer activities.

·       Maintain accurate and reliable records using electronic notebook, ensuring data integrity and adhering to good documentation practices.

·       Analyze and interpret QC data, identify trends, patterns and potential issues.

·       Collaborate with program management regarding QC testing schedule, test sample handling, equipment calibration and preventive maintenance activities.

·       Function as SME and provide technical leadership for cGMP manufacturing environment.

·       Train laboratory personnel and comply with all biological safety requirements. 

·       Provide oversight of external contract testing.

·       Manage QC quality records: out of specifications/invalids, investigations, deviations, change controls, etc.

·       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 or higher degree in science, biology, chemistry, or related field, or equivalent (graduate degree or certifications and continuing education).

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

·       Experience implementing, troubleshooting and maintaining instrumentation.

·       Experience with 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.

·       Experience with aseptic mammalian cell culture, automated cell enumeration, viability, phenotypic characterization.

·       Strong working knowledge of cGMP requirements.

·       Strong verbal and written communication skills, and experience with technical documentation, data analysis, and statistical tools.

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

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