Director, CMC Technology
10 hours ago
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.
Key Responsibilities: Technology Development & Innovation Leadership: · 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.
Client-Facing Responsibilities: · 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.
Cross-Functional Collaboration & Leadership: · 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.
Regulatory & Quality Interface: · 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.
Qualifications: · 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 Qualifications: · 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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
-
Watertown, Massachusetts, United States Disc Medicine Full time $157,250 - $212,750 per yearJoin our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.COMPANY OVERVIEW:Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio...
-
Watertown, Massachusetts, United States Orna Therapeutics Full timeWe're looking for an exceptional Director/Senior Director (commensurate with experience), Analytical Development to join our Process Development and Analytical Sciences (PDAS) team to lead analytical method development activities for Orna's oRNA-based lipid nanoparticle therapeutics from research to clinic. The ideal candidate will have analytical...
-
Watertown, Massachusetts, United States Prime Medicine, Inc. Full timeCompany Overview:Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially...
-
Watertown, Massachusetts, United States Prime Medicine Full timeCompany Overview:Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially...
-
Manager, Quality Assurance
1 week ago
Watertown, Massachusetts, United States Treeline Full timeAbout the roleThe Manager of Quality is responsible for supporting manufacturing, clinical and preclinical operations. This individual will be responsible for conducting audits of third parties, participating in the maintenance of a phase appropriate quality system, and the review of quality system and technical documentation. This individual will work...
-
Principal Scientist, Computer-Aided Drug Design
2 weeks ago
Watertown, Massachusetts, United States Psivant Therapeutics Full timePsivant Therapeutics is seeking a computational medicinal chemist with expertise in drug discovery, molecular simulations and AI/ML to join our dynamic, multidisciplinary team. Our science, our team, and our mission are focused on applying advanced computational technologies to progress a pipeline of innovative medicines for patients. We are looking for...
-
Watertown, Massachusetts, United States Psivant Therapeutics Full timePsivant Therapeutics is seeking a computational medicinal chemist with expertise in drug discovery, molecular simulations and AI/ML to join our dynamic, multidisciplinary team. Our science, our team, and our mission are focused on applying advanced computational technologies to progress a pipeline of innovative medicines for patients. We are looking for...
-
Operations Manager
1 week ago
Watertown, Massachusetts, United States Johnsonville Full timeAt Johnsonville, our Members are responsible for everything If you're passionate about making a difference, we want you to help make our products, our processes, our communities and each other better. As part of our manufacturing leadership and support group, you'll help ensure production and maintenance Members have the resources and support needed to work...
-
Watertown, Massachusetts, United States Acrivon Therapeutics Full timeAcrivon (NASDAQ: ACRV) is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon's proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3...
-
Director, CMC Technology
2 days ago
Watertown, United States Landmark Bio Full timeDirector, CMC Technology & Innovation Program LeadLandmark 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...
-
Watertown, United States Prime Medicine, Inc. Full timeDirector, Quality Assurance – Clinical and Nonclinical Development Company Overview: Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology,...
-
Watertown, United States Prime Medicine Full timeDirector, Quality Assurance – Clinical and Nonclinical Development Watertown, MA Company Overview: Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing...
-
Director of Software Engineering
5 days ago
Watertown, United States CDS Visual Full time $200,000Director of Software Engineering at CDS Visual summary: The Director of Software Engineering at CDS Visual leads R&D and development of innovative cloud-based SaaS digital products centered on 3D visualization and CPQ technologies. This role involves strategic leadership, cross-functional collaboration, and management of engineering teams to deliver...
-
Director - Education Early Childhood
2 days ago
Watertown, South Dakota, United States Our Little Village Learning Center Full timeJob OverviewThe Director of Education (DE) of Our Little Village Learning Center (OLVLC) is responsible for developing a quality daycare and preschool education curriculum that supports the learning goals of the center. The DE works with the Teachers to ensure that they are prepared to deliver the lesson plans and that the lesson plans meet the curriculum...
-
Senior Business Applications Admin
2 weeks ago
Watertown, MA, United States Evolv Technology Full timeJob Title: Senior Business Applications Administrator The Elevator Pitch Are you passionate about optimizing business systems and driving operational excellence? Evolv is seeking a Senior Business Applications Administrator to lead the administration of NetSuite and other key enterprise applications. This role is ideal for someone who thrives in a fast-paced...
-
SQA Intern
2 days ago
Watertown, MA, United States Evolv Technology Full timeInternship Title: SQA Automation Intern The Elevator Pitch Do you enjoy solving complex technical challenges and building automation that makes testing smarter, faster, and more reliable? Are you interested in working on real-world AI and machine learning systems that operate in safety-critical environments? Evolv is seeking an SQA Automation Intern to join...
-
Director of Software Engineering
4 weeks ago
Watertown, United States Dover Corp Full timeCDS Visual, a Dover operating company, enables manufacturers to drive business value by unlocking their CAD assets to deliver dynamic interactive visual experiences that support the complete customer and product lifecycle. Our cloud-based visualization solutions, trusted by the world's biggest industrial suppliers, revolutionize their commerce, configure...
-
Staff Product Manager, Marketing Technology
4 weeks ago
Watertown, United States Xometry Full timeXometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies to tap into global manufacturing...
-
Senior Director of Engineering
1 week ago
Watertown, South Dakota, United States Dakota Bodies Inc Full timePosition: Sr. Director of Engineering – Truck EquipmentPosition OverviewThe Sr. Director of Engineering – Truck Equipment provides overall strategic leadership, direction, and engineering excellence across the Truck Equipment business. This role is accountable for driving innovation, product development, technical execution, and engineering operations to...
