Landmark Bio ยท 3 months ago
Director, CMC Technology & Innovation Program Lead
Watertown, MA
Full-time
Onsite
Director/Executive
10+ years expLandmark Bio is dedicated to translating cutting-edge research into life-changing therapies. They are seeking an experienced and visionary Director, CMC Technology & Innovation Program Lead to drive the development of next-generation biomanufacturing platforms, focusing on continuous and integrated bioprocessing while collaborating with clients and leading internal innovation initiatives.
Biotechnology
Responsibilities
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
Qualification
Required
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
Preferred
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
Company
Landmark Bio
Landmark Bio is a biotechnology industry.
51-200 employees
H1B Sponsorship
Landmark Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
National Institute for Innovation in Manufacturing Biopharmaceuticals
2025-04-02Acquired
2025-03-17Grant
Leadership Team
Ran Zheng
Chief Executive Officer
Recent News
San Diego Business Journal
2025-04-22
2025-04-03
Company data provided by crunchbase