Scientist , Analytical and Quality Control

Position: Scientist 1, Analytical and Quality Control
Who is Blue Rock?Blue Rock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs.

Blue Rock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.
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.

As part of Blue Rock's vision to change the future of medicine by enabling ground-breaking cell therapies, we’re looking for a Scientist I/II with specialized knowledge of compendial sterility and safety methodologies used in the development and manufacture of cell therapy products, to support a dynamic and progressive Analytical and Quality Control team (A&QC). The position requires a data driven scientist with an analytical mindset who has great communication skills and will thrive in a cross-functional team environment.

Reporting to the Senior Manager (AD) within the Analytical and Quality Control (A&QC) organization, the Scientist will be a key technical contributor of an analytical team supporting our commitments to product quality of cell-based therapeutics destined for human clinical trials, from starting pluripotent stem cell materials to final differentiated cell therapy. The successful candidate will lead the execution of analytical strategy in support of Blue Rock’s pipeline, driving analytical method feasibility and development, qualification, transfer to GMP, and remediation, as well as the evaluation and adoption of new analytical and automated technologies.

Responsibilities:

Lead the development and maturation of Blue Rock’s microbiological/sterility and safety testing methodologies (adventitious agents, endotoxin, etc)

Liaise with multifunctional project teams to drive analytical and quality initiatives as they relate to progressing Blue Rock’s product pipeline

Serve as a scientific and technical subject matter expert to support the management of the analytical life cycle across multiple analytical methods, inclusive of analytical development, qualification, transfer to GMP, and remediation

Design and develop tests to support the safety and sterility of cell seeds, banks, intermediates, drug substance and drug products in the Blue Rock portfolio, and of raw materials used in the generation of said intermediates and products

Champion evaluating and implementing new technologies, processes, and analytical methods to enhance our product and process understanding, with a focus on the development and implementation of high-throughput analytical methods

Minimum Requirements:

Bachelors (10+ years)/Masters (9+)/PhD (1+) years of experience in a Biotechnology setting

Experience in analytical method development, qualification, validation, transfer, and remediation is essential

In-depth knowledge of microbiological/sterility/safety testing is required

A solid understanding of aseptic techniques and technologies in cell culture is required

Knowledge of and experience with high-throughput analytical method development and adaptation to liquid handling systems is preferred

Successful supervisory and mentoring skills in leading scientific and technical staff

Experience with Good Documentation Practices and working in a cGMP or equivalent environment is preferred

Excellent organizational and problem-solving skills, with demonstrated ability to work cross-functionally

Excellent written and oral communication skills, with strong organizational skills and keen attention to detail

Working knowledge of statistics and data trending using statistical programs and software is preferred.

Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).

Some travel may be required.

Salary Range: $104,/yr + Bonus

#LI-AL1