3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow for replacement of each individual patient’s parts with tissues designed and created specifically for them. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platforms include a full suite of features to meet the FDA’s requirements for therapeutic manufacturing, including novel and proprietary: 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In pre-clinical studies, the platform has demonstrated the ability to generate functioning living tissues and 3DBio is currently in clinical Phase 1/2a.
The Associate Director, Process Development will be responsible for leading a team of process engineers for the process technology innovation and development strategies of early and late-stage processes. We are seeking a dynamic, motivated individual with process development leadership experience to manage the daily process development activities. The position has accountability for the delivery of a portfolio of projects with direct oversight of multiple program and technology teams that drive rapid development and implementation of new technologies and processes into CMC programs and ensure functional excellence for regulatory strategies for future regulatory applications including INDs and BLAs.
This position will support both Manufacturing and R&D and work closely with other key stakeholders including Quality to perform and document manufacturing processes, support cGMP facility operations and upkeep and maintain cGMP compliance.
• Leads a team of process engineers to deliver robust and scalable operations leading to user-friendly cGMP operations and scale-up
• Supports technology transfer to clinical and commercial manufacturing
• Manages a team to assess the impact of process parameters on product performance, establish optimal parameters and controls, and execute phase-appropriate process characterization experiments
• Supervises, mentors, and develops process engineering staff
• Oversee process comparability and process validation studies including planning, execution, and documentation management
• Supports necessary technical experiments and analysis to enable decisions related to raw materials changes
• Prioritizes, develops, and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements
• Analyzes data and prepares presentations, data graphs, technical reports, and regulatory documents to support process-related decision-making and actively engages in scientific and technical discussions to support the decision
• Assures completion of daily process development workload. Works with Manufacturing management for the oversight of schedule for team resources
• Collaborates with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments
• Stays current with company industry standards, and all applicable regulations
• Creates, revises, and reviews controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing
• Builds effective cross-functional relationships both internally and within the clinical manufacturing team
• BS in Chemical/Mechanical/Biological Engineering with 10+ years of experience in engineering roles within a life sciences/biotech organization (with a significant portion of time focused on process engineering specifically) and experience managing engineering professionals (full-time employees and/or contractors/consultants)
• 8 years in process development and/or GMP environment is preferred.
• Understanding of cGMP, FDA, ISO, EMA, and ICH requirements
• 5+ years in a technical management role
• Ability to lead and manage teams including a track record of coaching and mentoring technical talent
• Demonstrated success in developing processes for pharmaceutical manufacturing of biotechnology products, aseptic processing, and cell therapy products
• Knowledge and experience of process development tools including the use of statistical design of experiments is required. Experience with automation technologies is desired.
• Excellent communication and presentation skills and aptitude for problem-solving
• Experience with the preparation of regulatory filings for US and external markets
• Excellent interpersonal, verbal, and written communication skills are essential