Analyst II, Analytical and Quality Control

Blue Rock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing our proprietary CELL+GENE™ platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.
Founded in 2016, Blue Rock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.
What Are We Doing?  Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies.
We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.
Who is Blue Rock?  Blue Rock 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  Analyst II, A&QC will support the QC Testing requirements of cell-based therapeutics destined for human clinical trials, from starting materials to final differentiated cell therapy. The AQC Analyst II will ensure QC Test methods are executed in a GMP compliant manner for samples generated by Manufacturing, including Raw Materials, Intermediates, Final Drug Product and through to Doses prepared for the clinic.

Duties will include writing and reviewing Standard Operating Procedures (SOPs) related to QC functions, and coordinating the revision, review, and approval of SOPs and other GMP documents that are necessary for ensuring testing is compliant with applicable U.S., Canadian and global standards.
Responsibilities   Effectively train on and execute assigned QC testing procedures and perform new assignments with general instructions and minimal supervision.
Support documentation for cGMP production, in-process testing, stability and release testing of cell therapy products
Support QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory, and reagent preparation.
Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods.
Review sampling plans and support COA issuance for batch disposition
Author or review GMP documentation for accuracy and compliance (e.g. methods, protocols, executed records) with thorough understanding of technical area of specialization.
Report and initiate quality events and leverage technical knowledge to define solutions to moderately complex problems.
Liaise with CROs for sample submissions and external testing results reporting.
Other duties as required.

Minimum Requirements   BSc in Life Sciences with minimum 3 years relevant experience in Cell Biology, Genetics, Biotechnology, Biochemistry or related field. MSc with minimum 1-year relevant experience preferred.
Strong preference for experience in Quality Control and experience with Good Documentation Practices and working in a cGMP or equivalent environment.
Experience in one or more of the following techniques is required: nucleic acid extraction, liquid handlers, qPCR, ddPCR,…