08 May Sr. Specialist, Supply Chain (Clinical)
Sr. Specialist, Supply Chain (Clinical)
Technical Operations · Cambridge, Massachusetts · Full time
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 Sr. Specialist, Clinical Supply will support BlueRock’s logistics operations incl. site logistics, & distribution for its clinical programs.
The role requires strong project management, communication and interpersonal skills combined with a background in GMP manufacturing and/or supply chain in the biopharmaceutical/pharmaceutical industry. This role will have routine interactions across different functions at BlueRock, with ownership of multiple external relationships. We’re looking for someone passionate, dynamic, and experienced in GMP manufacturing / project management / logistics with a strong desire to build and contribute to the Company’s goal of continuous improvement.
Responsibilities:
- Lead and support aspects of BlueRock’s clinical supply of cell therapy products during execution of early / late stage clinical trials
- Acts as the single point of contact for cell supply between the point of care, BlueRock Therapeutics and affiliates throughout the execution phase of BlueRock Therapeutics clinical trials
- Supports cross functional teams to develop and implement integrated preparation & distribution solutions for the cell dose, including the logistics & operations to provide the cell dose reliably & efficiently to the patient via the surgeon
- Collaborates with QA / regulatory / clinical operations partners to ensure compliance with GMP, GDP, and other applicable regulations; supports relevant investigations as required
- Supports ongoing transportation and logistics activities for domestic and international movements of cell products and supportive formulations and devices between distribution centers
Minimum Requirements:
- BS/MS in Life Sciences, Supply Chain Management or Engineering with a Bachelors w/ 8+ years of experience or Masters w/6+ YOE or PhD 2+ YOE
- Previous experience in managing biopharmaceutical supply chain, clinical operations and / or GMP operations / engineering
- Clinical supply experience a plus
- Cell therapy experience a plus
- Experience working in GMP environment and authoring protocols / procedures
- Project management basics including managing project schedules and budgets
- Ability to engage and align with other stakeholders within BlueRock as well as with external partners, and work effectively with cross-functional stakeholders in a complex / changing /global environment
- Demonstrated ability for critical thinking and innovation
- Team player willing to work in an environment where individual initiative, accountability, and professional maturity are required
- Ability to understand and communicate risks and develop and execute contingency plans for development programs
- Ability to manage projects across different functions and organizations
#LI-MM1
BlueRock Therapeutics Company Culture Highlights
- 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
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.
Please click here to apply.
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