Principal, Process Engineer
4 days ago
Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the best of industry, academia, and research hospitals to accelerate life sciences innovation. As a public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health.
Our founders include Harvard University, Massachusetts Institute of Technology, FUJIFILM Diosynth Biotechnologies, and Cytiva. Collaborating partners include Massachusetts General Hospital, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute and Boston Children's Hospital.
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. Together with our partners and collaborators, we are effecting broader changes in the healthcare industry and making a positive impact on people's lives and our society.
Position Summary:
The Process Engineering role requires expertise in GMP biomanufacturing process engineering and New Product Introduction (NPI)/ Technology Transfer (TT) into GMP facility for Viral Vector, Fill finish or Cell Therapy production. Additionally, the candidate must have Project Management (and PM tools) experience. Once the product has been transferred to production, the Process Engineer role will support ongoing production with Engineering and Technology expertise. The candidate will have excellent project management, technical scientific, and communication skills. This individual will work in a fast-paced team environment, collaborating with colleagues across functions in the organization to solve a wide range of complex problems in creative and practical ways. Position level will be dependent on relevant experience.
Scope of Responsibilities
• Note: the candidate must have Project Management (and PM tools) experience in addition to Process Engineering expertise.
• Project Planning: Develop detailed project plans outlining resources, costs, timelines, tasks, milestones, risks, contingencies, and mitigation strategies.
Project Management: Ensure clarity on team deliverables, provide routine status updates, and input to S&OP planning for project accuracy.
Resource Allocation: Ensure necessary personnel, equipment, and materials are allocated for successful NPI execution.
Risk Management: Identify potential risks, develop mitigation strategies for quality issues, regulatory compliance, and equipment compatibility.
Cross-functional Team Leadership: Lead cross-functional teams, ensuring project philosophies guide decision-making.
Technical SME: Represent Engineering & Technology as the technical GMP facility fit expert, ensuring process design alignment with facility capabilities.
Automation: Author and implement equipment recipes for single-use process equipment based on technology transfer packages.
Single Use Design: Collaborate with stakeholders and vendors to develop optimized Single Use Assembly designs.
Documentation: Author and manage GMP manufacturing documents, including process descriptions, batch records, critical raw material lists, and more.
Quality and Regulatory Compliance: Ensure NPI activities comply with regulatory guidelines and standards; prepare for Quality/Regulatory inspections.
Develop Client Proposals: Perform process fit assessments, define engineering/CAPEX requirements, and develop detailed project plans for NPI activities.
Continuous Improvement: Identify and implement opportunities for process optimization and cost reduction, maintaining or improving product quality.
Risk Assessments: Facilitate risk assessments/FMEA/RCA with cross-functional teams to manage business/quality risks.
Process Monitoring: Own daily process monitoring, including manufacturing data summary, analysis, and presentation.
Additional Responsibilities: Perform other tasks as required.
Qualifications
• Education: Minimum Bachelor of Science in Biotechnology, Biological Sciences, or Chemical Engineering.
• Experience: 10+ years in biotech scale-up, tech transfer, or manufacturing in the biopharma/biotech industry; 3+ years in functional or cross-functional team leadership.
• Project Management Certification: PMP, CAPM, Agile or other equivalent certification preferred. Experience with comparable hands-on management of projects and use of tools is accepted.
• Technical Expertise: Tech transfer and scale-up of biologic molecules for GMP production is required, including in-depth knowledge of process, equipment, single-use technology, validation, and facility fit.
• Facility Experience: Experience in design, qualification, start-up, or initial licensure of Biologics Manufacturing facilities preferred.
• Problem-Solving Skills: Strong ability to collaboratively address issues during transfer and routine production, working with cross-functional teams for timely solutions.
• Regulatory Knowledge: Understanding of cGMP manufacturing, analytical requirements, quality systems, and industry standards at all drug development phases.
• Additional Skills: Proficiency in MS Office Suite, statistical software, Visio, LIMS, SAP, Smartsheet, Veeva; strong communication skills; commitment to safety and operational support.
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