Director, CMC Technology & Innovation Program Lead

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.

The ideal candidate is an experienced and visionary Director, CMC Technology & Innovation Program Lead who will drive the development of next-generation biomanufacturing platforms, with a primary focus on continuous and integrated bioprocessing.

This individual will lead internal innovation initiatives and collaborate with clients to design and implement cutting-edge, connected unit operations for the continuous manufacturing of advanced therapeutics including extracellular vesicles and viral vectors. The ideal candidate brings deep technical expertise in continuous biomanufacturing and a strong track record of innovation and technology transfer in a regulated, GMP environment.

· Lead the strategic development and execution of advanced manufacturing technologies, with a focus on continuous biomanufacturing and connected upstream/downstream unit operations.

· Identify, evaluate, and implement innovative solutions that increase efficiency, reduce cost, and improve quality of GMP manufacturing processes.

· Partner with internal stakeholders and external collaborators to design and optimize end-to-end continuous manufacturing platforms.

· Serve as technical program lead on innovation projects, driving feasibility studies, proof-of-concept work, and scale-up activities.

· Engage with clients to develop and customize innovative manufacturing strategies, especially for early-phase clinical programs requiring continuous or intensified processing.

· Present technical strategies, development plans, and innovation roadmaps to clients, establishing confidence in the CDMO's platform and capabilities.

· Support business development efforts by contributing to proposals, technical discussions, and client onboarding activities focused on novel or non-traditional manufacturing solutions.

· Collaborate closely with Process Development, Analytical Development, Manufacturing, Engineering, and Quality to ensure seamless integration of new technologies into GMP workflows.

· Provide technical oversight and mentorship to scientists and engineers involved in innovation and technology development efforts.

· Partner with automation and digital teams to integrate data-rich control strategies and real-time monitoring into continuous platforms.

· Maintain accountability for CMC timelines, budget, resource planning, and key deliverables.

· Serve as the primary interface between CMC and program leadership, translating technical strategy into executable operational plans.

· Facilitate technical governance meetings, decision-making forums, and stage-gate readiness reviews.

· Ensure that technology development and implementation are aligned with current regulatory expectations for continuous manufacturing (e.g., FDA, EMA, ICH Q13).

· Support preparation of regulatory documentation related to innovative or continuous CMC processes (e.g., IND, IMPD, BLA sections).

· Drive implementation of Quality by Design (QbD) and Process Analytical Technology (PAT) frameworks into continuous platforms.

· Ph.D. or M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline.

· 10+ years of industry experience in biologics process development, with significant experience in continuous biomanufacturing and connected unit operations (e.g., perfusion, continuous capture, continuous chromatography, single-pass tangential flow filtration, integrated DSP).

· Proven experience leading innovation or technology development teams within a biopharma or CDMO environment.

· In-depth knowledge of GMP, regulatory requirements, and phase-appropriate development of continuous processes.

· Experience in process modeling, control strategies, and integration of PAT tools is highly desirable.

· Demonstrated ability to lead cross-functional teams and influence technical direction in a matrixed organization.

· Strong client-facing and communication skills, with ability to distill complex scientific concepts for diverse audiences.

· Familiarity with modular or closed-system biomanufacturing platforms.

· Experience with extracellular vesicle manufacturing.

· Experience with digital bioprocessing tools, automation platforms, or smart manufacturing systems.

· Prior experience supporting regulatory filings that include continuous manufacturing processes.

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

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability.