QC Microbiology 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. 

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.