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Director, Manufacturing Process Owner (Drug Substance & Drug Product)

bluerocktx · 30+ days ago

Berkeley, CA

Negotiable

Full-time

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Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.

The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

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[KWB1]
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

#LI-AL1

BlueRock Therapeutics Company Culture Highlights

Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023

Winner of Comparably's Award for Best Company for Diversity 2022

Winner of Comparably's Award for Best Company for Women 2022

Winner of Comparably's Award for Best CEO 2022

BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.

Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.

Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics

Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

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Last updated on May 8, 2024

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