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:
•Hire, develop and train an agile Quality Assurance - Systems team capable of implementing Quality Assurance - Systems processes to support cutting edge technologies for cell therapy, vector manufacturing and fill finish.
•Develop and implement the Quality Assurance - Systems program in support of the internal Quality Management System including GMP procedures and processes to support cutting edge technologies for cell therapy, vector manufacturing and fill finish.
•Review of GMP documentation to support the Quality Systems including Document Management, Change Control, Deviations, CAPA, Supplier Management, Risk and Audits.
•Support the implementation and quality oversight of GMP digital systems in a phase appropriate manner for the company.
•Ensure phase-appropriate compliance with cGMP regulations, guidance, and industry standards.
•Establish meaningful performance objectives and create a culture of continuous improvement.
•Actively develop staff and provide regular coaching and feedback.
•Partner closely with colleagues in Process Development, Manufacturing, and Quality Control to ensure effective technology transfers and right-first-time performance.
•Review and approve GMP manufacturing documentation including Standard Operating Procedures, Quality Records, and other documentation as applicable.
•Collaborate to close out deviations and change controls and ensure timely implementation of preventative and corrective actions.
•Ability to multitask and flexible to change utilizing risk-based and business-risk management techniques.
•Ability to readily shift priorities based on immediate needs.
Qualifications:
•Bachelor's degree in engineering, biology, chemistry, or a related field.
•8+ years of experience working in a GMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy.
•4+ years of effective management and strong leadership experience, with an excitement to both roll up your sleeves and be a thoughtful, company-wide partner.
•Extensive working knowledge of cGMP requirements and phase appropriate systems.
•Ability to manage and prioritize tasks and projects.
•Excellent verbal/written communication skills.
•Ability to multi-task, manage projects and track status to completion.
Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
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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