Associate Director of Regulatory Affairs CMC
- BlueRock Therapeutics
- Cambridge, Massachusetts
- Start date
- Mar 20, 2023
- Regulatory, Regulatory Affairs, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Full time
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.
This position is responsible for providing regulatory leadership and guidance to CMC teams developing cell and gene therapy products, including the oversight and generation of quality dossiers to support Health Authority meetings, clinical trial applications and market applications in the U.S. and multiple international territories. This role involves working closely with technical CMC teams, project teams, as well as serving as point for interactions with global health authorities to achieve alignment on the regulatory strategies to advance the BlueRock portfolio. Expertise and knowledge of global regulations and guidance for the development of cell therapy products is desired.Responsibilities:
BlueRock Therapeutics Company Culture HighlightsWinner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock 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.
BlueRock Therapeutics is a leading engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. BlueRock Therapeutics’ cell+gene platform harnesses the power of cells to create new medicines for neurology, cardiology, and immunology indications.
BlueRock Therapeutics’ cell differentiation technology recapitulates the cell’s developmental biology to produce authentic cell therapies, which are further engineered for additional function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore or regenerate lost function.
BlueRock’s culture is defined by scientific innovation, the highest ethical standards and an urgency to bring transformative treatments to all who would benefit. The company strives to be a top employer of scientific talent, empowering every member of the team to make meaningful and lasting contributions to the burgeoning field of regenerative medicine.
Become a BlueRocker! We are expanding our BlueRock team at all locations. Contact us on our website to learn about rewarding career opportunities.
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