Director, Manufacturing Process Owner (Drug Substance & Drug Product) - BlueRock Therapeutics

The Director, Manufacturing Process Owner (Drug Substance & Drug Product) is a key technical role that is meant to anchor BlueRock development and manufacturing activities at the Bayer-Berkeley site. This role will provide scientific and technical oversight for activities occurring in the development space as well as the cGMP space related to BlueRock’s cell therapy candidates.

• Driving tech transfer related activities,
• Providing sound scientific expertise as manufacturing processes are established and confirmed,
• Facilitating technical discussions across sites and organizations to troubleshoot manufacturing challenges,
• Authoring, reviewing, and approving technical documents including but not restricted to: draft batch records, process descriptions, production summaries, root cause analyses, etc.
• Developing and delivering training materials,
• Coordinating manufacturing floor support for general oversight of technical transfer activities,
• Ensuring that day to day tracking and progress is maintained to meet overall project timelines,
• Managing the impact of scope changes during technical transfer activities,
• Working with Supply Chain/Logistics, ensure raw materials and component readiness through design, testing and release for use,
• Developing risk-based strategies for technical oversight accounting for product life cycle, technical complexity and site capabilities.

• 10+ years of experience with a Ph.D. in Chemical/Biological Engineering or related Life Science discipline
• 15+ years of experience with a Master’s Degree in Chemical/Biological Engineering or related Life Science discipline
• Expertise developing and/or providing technical support of commercial or late-stage clinical scale cGMP manufacturing, including cell culture or stem cell-based products
• Has a strong working knowledge of the Quality and Regulatory aspects of cGMP production, tech transfer, and process development.
• Experience in production of iPSC or other stem cell programs strongly preferred.
• Exceptional collaboration and communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network
• Experience leading teams, building manufacturing and business processes.
• Experience with Quality Management systems including CAPAs, Change and Deviation management
• Demonstrated experience and solid understanding of process characterization, process validation and comparability in cell culture or stem cell manufacturing
• Ability to maintain integrity, respect and honesty at all times, reliably meet commitments, communicate status updates and issues, obtain resources and track status to drive resolution of open issues
• Develops and delivers effective presentations with strong written and verbal communication
• Problem-solving and critical thinking skills
• Ability to train others on basic systems and processes
• Ability to work in an ever-changing environment