Landmark Bio
Associate Director of Quality Assurance Operations
Landmark Bio, Watertown, Massachusetts, us, 02472
Landmark Biotranslates 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 an 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 - Operations team capable of implementing Quality Assurance - Operations processes to support cutting-edge technologies for cell therapy, vector manufacturing, and fill finish.Provide quality oversight of phase-appropriate GMP technical operations, including manufacturing, supply chain, warehouse, and facilities.Provide quality oversight of QC testing, including method transfer, qualification, release, and stability testing.Review of GMP documentation to support the disposition of Raw Materials, Critical Reagents, Drug Substances, and Drug Products (including Lot Packets and Batch Records).Serve as a Quality Point of Contact with all Client-facing activities, including quality events triage, routine communication and notifications, and change management.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.Ensure adequate resourcing to support production schedules and timely lot disposition.Review and approve GMP manufacturing documentation including Standard Operating Procedures, Batch Records, and equipment records.Collaborate to close out deviations and change controls and ensure timely implementation of preventative and corrective actions.Develop and maintain Product disposition timelines and maintain close communication with customers/clients regarding the status/changes to processes.Qualifications
Bachelor's degree in engineering, biology, chemistry, or a related field.8+ years of experience working in a biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy.Extensive working knowledge of cGMP requirements and phase-appropriate systems.Strong leadership skills, with an excitement to both roll up your sleeves and be a thoughtful, company-wide partner.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.
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Hire, develop and train an agile Quality Assurance - Operations team capable of implementing Quality Assurance - Operations processes to support cutting-edge technologies for cell therapy, vector manufacturing, and fill finish.Provide quality oversight of phase-appropriate GMP technical operations, including manufacturing, supply chain, warehouse, and facilities.Provide quality oversight of QC testing, including method transfer, qualification, release, and stability testing.Review of GMP documentation to support the disposition of Raw Materials, Critical Reagents, Drug Substances, and Drug Products (including Lot Packets and Batch Records).Serve as a Quality Point of Contact with all Client-facing activities, including quality events triage, routine communication and notifications, and change management.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.Ensure adequate resourcing to support production schedules and timely lot disposition.Review and approve GMP manufacturing documentation including Standard Operating Procedures, Batch Records, and equipment records.Collaborate to close out deviations and change controls and ensure timely implementation of preventative and corrective actions.Develop and maintain Product disposition timelines and maintain close communication with customers/clients regarding the status/changes to processes.Qualifications
Bachelor's degree in engineering, biology, chemistry, or a related field.8+ years of experience working in a biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy.Extensive working knowledge of cGMP requirements and phase-appropriate systems.Strong leadership skills, with an excitement to both roll up your sleeves and be a thoughtful, company-wide partner.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.
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