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 today’s cutting-edge research into tomorrow’s breakthrough therapies.

We are seeking a Manufacturing Engineer, Level 4 to perform daily Cell Therapy manufacturing processes, and function as on-the-floor lead during daily operations. Perform hands-on operations, serve as subject matter expert & work closely with Process Development, Facilities, Process Engineering, Quality Control & Quality Assurance to support batch documentation, deviation investigations, corrective/preventive actions, and new technology introduction.

● Oversee and execute day-to-day manufacturing operations in the GMP facility.

● Maintain document and equipment readiness for scheduled activities, and an inspection ready manufacturing environment to deliver on-time, error free batches.

● Perform Cell Therapy (CT) and/or Viral Vector (VV) manufacturing, including both upstream and downstream activities and aiding with Fill Finish (FF) activities.

● Responsible for appropriate training of new employees and existing team members on core procedures (GMP gowning, Personnel and equipment flow and Routine Lab cleaning).

● Interact with clients as part of the cross-functional tech transfer team and during manufacturing campaigns, acting as the Manufacturing Operations SME and point of contact for any person-in-plant (PIP) as needed.

● Develop a scenario of options for any rescheduling required due to changes to production needs.

● Own manufacturing deliverables and decisions as the manufacturing SME on the cross-functional team during tech transfer activities.

● Provide resources and subject matter expert (SME) input to support continuous improvement, capital, and corporate initiatives.

● Lead the troubleshooting of process and equipment problems in conjunction with relevant support SME, ensuring immediate mitigation to prevent impact to safety or product quality. Provide manufacturing options to be endorsed by management and clients.

● Function as System Owner for Manufacturing Equipment, including Data Integrity Assessment, Alarm Management, User Requirements Specification

● Collaborate with Facilities, Engineering and Validation to maintain equipment.

● Work closely with management to develop processes/techniques to meet contract objectives and avoid operational delays. Champion implementation of lean manufacturing initiatives.

● Generate, revise, review and adhere to quality documents (SOPs, forms, batch records).

● Create and revise on-the-job training documents for GMP manufacturing equipment and processes.

● Own and drive quality records (e.g., deviations, CAPAs, Change Controls, Risk Assessments) in support of GMP readiness and continuous improvement.

● Facilitate cross functional RCA or Risk Assessment sessions.

● Perpetuate a culture of Safety and Quality compliance and continuous improvement.

● Master's degree in Biochemistry, Chemistry, Biomedical/Chemical Engineering or a closely related field with two (2) years of experience in Cell Therapy (CT) GMP Manufacturing.

● The above experience must also include:

● Two (2) years’ experience working with:

■ CliniMACS Prodigy, NC202 (Nuclear counter), and Cocoon fermentation system.

■ Upstream or downstream Viral Vector GMP manufacturing, including cell expansion, WAVE bioreactors, XDR bioreactors, depth filtration, AKTA Ready chromatography system, KR2i TFF system and Fill Finish.

■ Aseptic technique.

■ Equipment commissioning and validation.

● One (1) year of leadership experience with manufacturing teams or a continuous improvement initiative.

● Qualified candidates must be proficient in Veeva (QMS), xCellit (EBR), Smartsheet, and MS Office.

This is a lab-based, on-site position.

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