3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow the 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 Senior Manager, Clinical Manufacturing will be responsible for the performance of manufacturing, materials processing, and general testing for development, pilot, and cGMP aseptic manufacturing in accordance with well-defined standards and procedures. We are seeking a dynamic, motivated individual with manufacturing leadership experience to manage the daily manufacture of multiple products in support of the company’s clinical-stage and R&D platforms. This individual will be expected to be an active resource for the team on the floor in a generalist capacity and assist in creating a positive work environment. This individual will also provide support to other groups such as Quality Control, Quality Assurance, and Research.

This position will support both Operations and Development 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.

Responsibilities:

  • Leads a team that consistently produces clinical products while ensuring cGMP compliance through oversight and education of team members
  • Develops schedules of workflows to streamline manufacturing processes from initiation to release
  • Creates partnerships and systems to produce development and preclinical product to support R&D needs for pipeline projects
  • Manages scheduling of lots in coordination with cross-functional groups. Drives resource planning such as materials, personnel, and equipment to ensure seamless operation of manufacturing activities
  • Assures completion of daily manufacturing workload. Oversight of schedule for team resources
  • Leads, investigates and 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
  • Oversees cold chain shipping and logistics for incoming tissue and outgoing clinical product
  • Lead the receipt of technical transfers from Process Development team, assisting with processing COGs and timelines, and initiating manufacturing suite set-up.
  • Receives and manages equipment alarms
  • Supports compilation of manufacturing metrics, data, reporting, and process improvements.
  • Builds effective cross-functional relationships with R&D and Quality and within the clinical manufacturing team

Job Requirements

  • BS in Chemical/Mechanical/Biological Engineering with 10 years in aseptic in a biopharmaceutical or medical device (preferably in biologics/cell therapies) environment
  • 8+ years in a cGMP environment with an excellent understanding of federal regulations for Quality Systems (21CFR820) and cGMP manufacturing (21CFR 210,211)
  • Aseptic manufacturing of Advanced Technology Medicinal Products experience preferred
  • 5+ years in a supervisory role and possessing training and scheduling experience
  • Proven track record of managing a cGMP facility. Ability to lead and manage teams including experience coaching and mentoring manufacturing staff.
  • Strong ethical foundation
  • Excellent interpersonal, verbal, and written communication skills are essential