Senior Director, Manufacturing Technical Operations

Just Bio is seeking a highly motivated Senior Director, Manufacturing Technical Operations, that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to lead and guide a group of process, automation, and validation engineers in the execution and support of late stage clinical and commercial biologics manufacturing operations. The primary job responsibilities will include process and technology transfer; GMP manufacturing and technical documentation generation and maintenance (e.g., manufacturing and operating procedures); equipment and utilities commissioning and validation; process validation; process automation implementation and validation; and advanced biologics manufacturing technology implementation. Additional job responsibilities will include troubleshooting and/or providing technical expertise to perform or lead investigations, assist in the generation of relevant regulatory submissions, implementation/maintenance of cGMP compliant systems, and provide support for regulatory and site inspections.

Educational Requirements:

  • PhD or Master’s degree in biological or engineering science with 15+ years relevant experience or
  • Bachelor’s degree in biological or engineering science with 20+ years relevant experience

Qualification Requirements:

  • Previous experience in late-stage/commercial biologics manufacturing
  • Technical mastery of cell culture and purification operations at commercial scale
  • Proven knowledge of cGMP requirements to ensure compliance
  • Validation experience, including risk assessments, user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports
  • Strong understanding of process automation (e.g. DeltaV) and BAS systems
  • Previous experience managing the activities of individuals, work groups, and project teams.
  • Candidate must possess strong focus on quality and attention to detail
  • Possess effective task/time management organizational skills
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • Thorough working knowledge of US FDA CFRs and European EMA, including ICH regulations
  • In-depth knowledge of equipment, operations, and engineering principles
  • Experienced in technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
  • Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
  • Active participation/lead technical projects with collaborators and vendors