Project Coordinator, External Manufacturing
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:
BlueRock Therapeutics is seeking a Project Coordinator, External Manufacturing to support their outsourced GMP manufacturing operations. Reporting to the Supply Chain Manager, this position will have accountability for managing the relationships and delivery of services and products from the contract development and manufacturing organizations used for cell banks, process intermediates and drug product including GMP production of clinical materials.
By working with internal BlueRock teams and staff from contract manufacturing/development organizations, we’re looking for someone who can facilitate the successful contract development and manufacturing of cell banks, process intermediates and drug product (Qualification lots, clinical GMP production) to BlueRock specifications and timelines.
Responsibilities:
- Build and maintain a strong relationship between BlueRock and CDMO; act as the primary interface representing BlueRock on an ongoing basis, demonstrating and representing all BlueRock values and operating requirements.
- Drive clarity around goals, milestones and timelines while tracking and influencing deliverables; present and communicate with multiple levels of BlueRock management, providing regular updates on technical transfer and manufacturing operations.
- Provide oversight of BlueRock’s interests at the CDMO during manufacturing; track project activities and manufacturing operations to transfer back to BlueRock including our product, samples, documentation, and data under appropriate GMP and regulated requirements and as per master service agreements and CDAs in place.
- Obtain process and operational metrics and reports, production summaries for regulatory filings, and working with CDMO’s on details of questions or responses from regulators.
- Ensure logistical and resource needs are identified, communicated, and fulfilled; manage the transfer of information (raw material specs, process description, batch documentation, sampling plans, equipment specs, quality control requirements, etc.) to the CDMO for successful preparations, readiness, and monitoring.
- Participate in site audits, future CDMO assessments and play the role of person-in-the plant during production campaigns, providing direct observed oversight of BlueRock’s production interest at the CDMO.
- Coordinate and collaborate with other teams within BlueRock to facilitate successful batch manufacture at the CDMO.
- Support the Mars7 GMP pilot facility with the procurement of production material as required by the manufacturing team
Requirements
- A minimum of a Bachelor’s in scientific field with 2+ years relevant experience or equivalent combination of education and experience
- A minimum of 1 + years’ experience in project management and tech transfer
- Willing to travel (approx. 10% of the year)
- A well-developed understanding of Cell Therapy products, characteristics, production processes and expectations, and the ability to use this knowledge to work through risks and issues that occur.
- Ability to influence and create a sense