Senior 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

·         Adheres to all safety protocols and maintains safe work habits in compliance with organizational and regulatory standards.

·         Performs aseptic operations for cell culture, viral transfection, cell harvesting, and purification processes, ensuring contamination control and compliance with GMP.

·         Collaborates with cross-functional teams, including Quality Assurance, Quality Control, and Process Development, to support continuous improvement initiatives and maintain manufacturing readiness.

·         Executes manufacturing operations for cell and gene therapy products, with a focus on viral vector production and cell processing in a cGMP-compliant environment.

·         Completes and documents all required training before performing cGMP manufacturing activities.

·         Handles equipment assembly, operation, disassembly, and cleaning, ensuring readiness and cleanliness standards are met.

·         Follows and accurately documents standard operating procedures (SOPs) and batch records, ensuring thorough and precise data entry.

·         Supports document management by assisting with authoring, updating, and revising batch production records and SOPs.

·         Assists in implementing new manufacturing technologies and procedures to enhance operational efficiency and effectiveness.

·         Contributes to training efforts by supporting the onboarding and development of team members.

·         Serves as a Subject Matter Expert (SME) for designated equipment, providing technical support and guidance.

·         Participates in technical transfer activities to integrate processes into the cGMP facility effectively.

·         Leads or supports investigations as needed to address process deviations and implement corrective actions.

·         Applies process knowledge to resolve manufacturing issues and identify areas for continuous improvement.

·         Engages in cross-functional teams to drive deviation investigations, conduct root cause analysis, and support Corrective and Preventative Actions (CAPAs).

Qualifications

·         Bachelor’s degree with a minimum of 2 years of experience in a cGMP manufacturing environment, or a combination of relevant education and experience.

·         Experience in cell processing, viral vector production, and single-use platforms is preferred.

·         Working knowledge of cGMP and regulatory standards with familiarity in deviation management, CAPAs, and Change Control processes.

·         Ability to perform aseptic gowning and execute manufacturing tasks while adhering to gowning and personal protective equipment (PPE) standards.

·         Proficient in basic computer skills with a willingness to learn new systems and adapt to emerging technologies.

·         Strong organizational and interpersonal skills, with excellent written and oral English language communication abilities.

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