Process Specialist II/Sr. Process Specialist
BlueRock Therapeutics, Canada
Job Description
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.
Description of Position:
As part of BlueRock's vision to change the future of medicine by enabling ground-breaking cell therapies, the successful candidate will be a key technical contributor to a dynamic and progressive team focused on developing novel therapeutics.
We are looking for an MSAT Process Specialist II/Senior Process Specialist, reporting to the Senior Manager MSAT, to provide process improvement and technical support for technology transfers, scale-up/scale out, process understanding and GMP manufacturing. Additionally, draft and review protocols, standard procedures, and process summary reports, and provide technical assessment for internal and external collaborators on process changes as well as documentation pertaining to process development, characterization, and validation to meet regulatory requirements. This role will focus on aspects of ensuring an automated, robust, and efficient manufacturing processes to produce human clinical trial and commercial cell-based products.
The candidate will be highly motivated with experience developing and scaling cell and gene therapy manufacturing processes. The ability to communicate complex topics and assume a broad range of responsibilities is critical. Collaboration with a highly motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for a talented and highly motivated individual.
Responsibilities:
- Perform standard scientific assignments which are typically a significant portion of a larger project.
- Work closely with lead scientists to execute process improvement, technology implementation, and technology transfer projects.
- Assist in developing new or improved techniques and procedures around specific tasks with minimal supervision.
- Assist in developing new technologies to support transition to commercial manufacturing, including implementation of cutting-edge automation technologies to improve manufacturing process robustness.
- Assist in developing and implementing technologies to enable Process Analytical Technologies (PAT) in the manufacturing processes.
- Select sound techniques to solve problems, evaluate changes and make design recommendations under direct supervisor.
- Work independently or with other technical personnel to execute experiments.
- Possess knowledge of statistical analysis to draw appropriate conclusions from the data.
- Interface and collaborate with external sites to ensure success of scale up/process transfer.
- Document experimental data in a timely and accurate manner
- Present and effectively communicate scientific concepts, experimental observations, and rationale to colleagues.
- Perform laboratory duties in a safe and efficient fashion.
Requirements
- Minimum of a Bachelor’s Degree in engineering, life sciences or related field with 2 + years (Specialist II) or 5+ years (Sr. Specialist) of relevant experience OR Master’s Degree with 0 3+ years of relevant experience is required.
- Extensive experience in mammalian cell culture, including cell harvest, aseptic fill amp; finish, and cryop