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.
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, team-oriented QC Analyst II to join our Microbiology team, reporting to the QC Manager of Microbiology, Saturday through Wednesday shift.
Responsibilities:
• Independently perform routine Microbiology activities including; Environmental Monitoring, Bioburden, Endotoxin, Sterility,
Growth Promotion, APS, APQ, and Utility Monitoring per Landmark Bio standard operating procedures and test methods.
• Document all testing performed according to applicable cGMP, GDocP, and GLP.
• Operate laboratory equipment and instruments in accordance with cGMP, safety, and housekeeping requirements.
• Maintain testing materials and supplies for QC Microbiology laboratory.
• Participate in the execution of method qualifications for sterility, bioburden and endotoxin; support execution of EM validation
activities (EMPQ, risk assessments etc.)
• Responsible for Initiating and owning quality events; deviations, CAPAs and change controls.
• Author and approve documentation, including test methods and standard operating procedures.
• Coordinate and work with external contract testing laboratories and internal cross-functional teams.
• Flexibility to work occasional late hours and weekends as needed.
• Additional job responsibilities as agreed with the manager.
Qualifications:
• Bachelor’s degree in microbiology, Biology, or STEM equivalent.
• 3+ years of experience working in a QC Microbiology lab/ GMP cleanroom environment, performing Sterility, Endotoxin, and
Environmental Monitoring.
• Experience with rapid sterility (BacT) and Endotoxin (MCS) systems and USP test methods preferred.
• Excellent verbal and written communication skills.
• Detail oriented, critical thinker able to work cooperatively in a team setting.
Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
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What We Do
Landmark Bio is a collective endeavor launched by leaders from academia, the life sciences industry, and world-renowned research hospitals to accelerate development and industrialization of next-generation genomic medicine. Inspired by recent advancements in cell and gene therapy, Landmark Bio was established to remove barriers in drug development, create accessible capability, expertise, and solutions, and offer a collaboration platform to advance manufacturing technologies for the new generation of medicines to come. Founding partners include Harvard University, Massachusetts Institute of Technology (MIT), Cytiva, FUJIFILM Diosynth Biotechnologies (FDB), and Alexandria Real Estate Equities, Inc. Other collaborating institutions include Beth Israel Deaconess Medical Center, Boston Children’s Hospital, Mass General Brigham, and the Dana-Farber Cancer Institute. For more information please contact [email protected]
Why Work With Us
Landmark Bio was conceived to accelerate life sciences innovation. Our cross-sector network, expert staff and consultants, state-of-the-art facility, and broad definition of how a true partner can expedite translational research make us unique. Our mission Is to translate groundbreaking research into life-changing therapies.
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