Sr. Manager, QC Microbiology

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.

Scope of Responsibilities

·       Recruit, hire and train an agile QC Microbiology team, providing leadership, mentoring and career development.

·       Manage and oversee all QC Microbiology testing, including rapid sterility and other Micro safety testing, and environmental monitoring.

·       Ensure compliance with cGMP regulations, guidance, and industry standards such as cGMP and USP.

·       Provide management oversight for right first-time execution of environmental monitoring (water, steam) and utilities (air, compressed gas, HVAC).

·       Process owner for EM and Utility programs, responsible for routine trending and driving continuous improvements.

·       Provide technical expertise in areas of QC Microbiology, including microbiologic identification, aseptic gowning, and environmental monitoring.

·       Responsibility for the qualification of bioburden and endotoxin samples.

·       Manage and own laboratory out of trend investigations, deviations and other quality records.

·       Participate in audits and conduct internal audits to assess compliance with cGMP and other regulatory requirements.

·       Author, review and approve technical documents, including SOPs, validation protocols, technical reports and regulatory submissions.

·       Partner and collaborate with other stakeholders, including Manufacturing, Process Development, Analytical Development and Quality Assurance to ensure effective technology transfers and method qualification, right first-time performance and drive continuous improvement.

Qualification

·       Advanced degree in Microbiology, or other related fields (graduate degree or certifications and continuing education a plus).

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

·       4+ years of supervisory / management experience.

·       Strong working knowledge of cGMP requirements.

·       Strong management and leadership skills, with a proven ability to lead and motivate teams.

·       Ability to manage and prioritize tasks and projects, and with excitement to both roll up your sleeves and be a thoughtful partner.

·       Excellent verbal and written communication, and interpersonal skills.

·       Proficiency with data analysis and statistical methods.

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