Senior Analyst, Analytical and Quality Control

BlueRock 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 CELLGENE platform we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.

Founded in 2016 BlueRock 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 BlueRock

BlueRock Therapeutics a wholly-owned and independently operated subsidiary of Bayer AG is a leading engineered cell therapy company using its unique cellgeneplatform 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 novelcellgeneplatform 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

Ourfoundational scienceharnesses 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:

The Analytical and Quality Control (A&QC) Senior Analyst Compliance will provide support for a wide variety of A&QC Compliance requirements for the laboratory activities facilitating testing of cell-based therapeutics destined for human clinical trials. The Senior Analyst will be one of the key contributors in driving all aspects of the QC laboratory compliance through appropriate quality systems. The candidate will report to the Associate Director A&QC and work closely with all subgroups (i.e. Testing EM Ops etc.) within A&QC to provide support in quality aspects. The Senior Analyst will be instrumental in ensuring compliance within the laboratory through issues change controls deviations lab investigations CAPAs change actions and audit support. The candidate will also support management of documentation. Duties include control of the GMP documentation and data generated aiding in the quality and compliance of the laboratory operations and data integrity for testing in the QC lab to meet applicable U.S. Canadian and global standards.

Responsibilities:

• Work closely with Quality Assurance (QA) and A&QC assay SMEs or process owners to support management of QC-related quality records in the electronic Quality Management System (eQMS) i.e. issues change controls deviations lab investigations CAPAs change actions and audit activities relevant to testing equipment and processes etc.
• Handle routine quality records independently and have the capability to advance the ones with moderate complexity under minimal supervision.
• Be involved in drafting and pushing quality records for on time closure and/or guiding the quality record owners (i.e. QC assay SMEs) to achieve.
• Track and update the progress of all quality records pertaining to QC at regular basis.
• Participate workflow improvement within eQMS as needed.
• Support authoring and review of SOPs related to QC activities and provide QC input for cross-functional SOPs relating to general GMP compliance.
• Support management of QC documentation workflow including GDP compliance of laboratory records.
• Triage supplier change notifications (SCNs) assigned to A&QC and coordinate with SMEs/management for closure and/or change control initiation
• Other duties as required.

Minimum Requirements:

• Minimum of a Bachelors degree in Biological Sciences or related field with a minimum of 5 years of relevant experience in the industry is required OR a Masters degree with 3 years relevant experience is required.
• Experience in Quality Control within the Biotechnology setting is a must strong preference particularly for experience in Cell therapies in a cGMP-compliant environment.
• Highly familiar with laboratory operations standard procedures and instrumentation for testing of biologicals is preferred.
• Compliance mindset for the execution of elements within the quality system including Change control Deviation management and CAPA implementation.
• Competency in computer skills and familiarity with Microsoft Office (Word Excel PowerPoint).
• Excellent written and oral communication skills with strong organizational skills keen attention to detail and proven ability to be highly productive and successful in a high pace work environment.

Work Environment

• In this position you will work in a controlled laboratory environment
• You may be periodically required to move heavy equipment around up to 50 lbs
• Working in the laboratory requires mandatory use of personal protective equipment

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.

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.