Sr. Manufacturing Associate/Manufacturing Associate

Landmark Bio•Watertown, MA

About The Position

Landmark Bio is dedicated to translating cutting-edge research into life-changing therapies. Headquartered in Watertown, Massachusetts, the company was founded by leading academic institutions, research hospitals, and industry partners to accelerate the development, manufacturing, and commercialization of advanced therapies. Driven by the compelling science and transformative potential of genetic medicine, Landmark Bio offers deep drug development expertise and integrated end-to-end solutions to support its partners. The company also serves as a collaborative platform to advance next-generation manufacturing technologies for novel modalities. Following its acquisition by Artis BioSolutions in 2025, Landmark Bio continues to operate as a distinct entity. Learn more at www.landmarkbio.com. 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 todayâs cutting-edge research into tomorrowâs breakthrough therapies. We are seeking a highly motivated, team-oriented, and entrepreneurial-minded individual for the position of Sr. Manufacturing Associate/Manufacturing Associate in Landmark Bioâs Manufacturing Operations group. Manufacturing Operations is responsible for executing cell therapy, vector manufacturing, fill finish and production support operations following current Good Manufacturing Practices (cGMP) in cleanroom environments to produce materials for use in early-stage clinical trials. In addition to hands-on operations, Sr. Manufacturing Associates work with colleagues in Process Development, Facilities & Engineering and Quality Assurance to support batch documentation, deviation investigations and corrective actions, and new technology introduction. This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning todayâs cutting-edge research into tomorrowâs breakthrough therapies. Together with our partners and collaborators, we are effecting broader changes in the healthcare industry and making a positive impact on peopleâs lives and our society.

Requirements

Bachelorâs 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.

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).