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.
Responsibilities:- 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.
Minimum Requirements:- 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
$200,000 - $230,000 a year
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