Lead Manufacturing Associate

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

·       Promotes and enforces safety culture by actively following all safety procedures, championing safe work habits, and leading by example.

·       Leads aseptic operations for cell culture, viral transfection, cell harvesting, and purification processes with minimal oversight, ensuring strict contamination control and adherence to cGMP requirements.

·       Acts as a cross-functional liaison, collaborating closely with Quality Assurance, Quality Control, and Process Development teams to drive manufacturing readiness, continuous improvement, and operational excellence.

·       Oversees and executes complex manufacturing operations for cell and gene therapy products, with a primary focus on viral vector production and cell processing, while ensuring compliance with cGMP standards.

·       Completes and verifies training compliance for self and team members before engaging in cGMP operations; maintains comprehensive training documentation and ensures alignment with regulatory and quality requirements.

·       Manages equipment assembly, operation, disassembly, and cleaning, overseeing routine maintenance checks and troubleshooting to ensure seamless operation.

·       Leads the meticulous execution of SOPs and batch records, ensuring data accuracy, integrity, and compliance in all logs, forms, batch records, and electronic systems.

·       Authors, manages, and revises documentation for batch production records, standard operating procedures (SOPs), and other essential documents, taking ownership of document quality and version control.

·       Drives the introduction and implementation of new manufacturing technologies and procedures, serving as a change agent to streamline processes and optimize performance.

·       Mentors and trains junior team members, fostering technical and procedural expertise within the team; provides ongoing coaching and development to elevate team capabilities.

·       Acts as a Subject Matter Expert (SME) for complex equipment, leading troubleshooting efforts, and providing expertise to resolve equipment-related challenges efficiently.

·       Oversees technical transfer processes for new and existing processes into the cGMP facility, ensuring successful scale-up and integration within the manufacturing environment.

·       Leads and participates in investigations, utilizing process understanding and analytical skills to identify root causes, implement Corrective and Preventive Actions (CAPAs), and ensure continuous improvement.

·       Champions deviation investigations and CAPA implementation on cross-functional teams, driving accountability for timely resolution and proactive identification of process

Qualifications

·       Bachelor’s degree with 4+ years of experience in cGMP manufacturing or an equivalent combination of advanced education and relevant experience, preferably in cell processing, viral vector production, or related biotechnologies.

·       Experience in cell processing, viral vector, and single-use platforms with a demonstrated ability to lead and manage complex manufacturing processes independently.

·       In-depth knowledge of cGMP and regulatory standards with experience leading audits, implementing CAPAs, and managing change control processes.

·       Expertise in Deviations, CAPAs, and Change Controls, with a track record of supporting investigations, root cause analysis, and preventive measures across teams.

·       Proven leadership in aseptic processing and gowning requirements, ensuring full compliance with gowning/PPE standards and aseptic techniques.

·       Basic computer skills with the ability to learn new systems and understand new technologies.

·       Exceptional organizational, interpersonal, and communication skills, with a demonstrated ability to lead teams, resolve conflicts, and communicate effectively at all levels.

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