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 cellgene 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 cellgene 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.
Senior Toxicologist is responsible for coordinating nonclinical development of BlueRock programs, including but not limited to, toxicology, tumorigenicity, biodistribution, and local tolerance of human induced pluripotent stem cell (hiPSC)-derived authentic cells prior to initiating clinical trials.
The toxicologist will help to develop strategies for nonclinical IND-enabling studies with program teams to enable clinical testing.
Will provide input as a technical expert within the immediate function and within a multidisciplinary project team.
This dynamic position will work closely with program team members across various functional groups within BlueRock, assure nonclinical development studies (both GLP and non-GLP) are performed according to the study protocol at external CROs, and to prepare and compile nonclinical documents for regulatory submissions.
An ideal employee will be passionate to contribute to the advancement of programs and to deliver safe therapies to patients.Responsibilities: A nonclinical development representative of project teams throughout various program stages of the life cycle.
Support and advise Research in nonclinical safety and biodistribution evaluation of earlier stage programs; identify deficiencies and aid to fill data gaps to advance programs to development.
Interact cross-functionally with key stakeholders to advance the program based on the non-clinical development strategy.
Work closely with Toxicology Operations on vendor qualification, study set-up, protocol development, study monitoring, data and report review, and maintain timeline and study budget for each study.
Ensure GLP compliance and appropriateness of nonclinical model welfare at CROs.
Act as a Sponsor Representative on nonclinical studies performed at CROs and maintain active communication line with the CRO.
Align study designs and dose setting within Preclinical Development and Project Team.
Maintain project timeline and deliverables for all nonclinical activities.
Independently ensures the preparation of technical documents, including position papers, risk assessments and safety summaries.
Compile nonclinical portion of regulatory submission documents (e.g., IND/CTA, regulatory interactions).
Communicate with clinical team on the clinical development plan, review clinical protocol, compilation of Investigator’s Brochure, and provide input to Target Product Profile.
Collaborate on externally partnered programs, as necessary.
Perform program due diligence, as assigned.
Coordinate with consultants, as needed.
Provide written and oral presentations internally and externally, as required.
Participate in project sub teams or departmental working groups.
Minimum Requirements: PhD or a degree commensurate with experience.
American Board of Toxicology (ABT) certification is a plus.
A minimum of three (3) years of toxicology experience in pharmaceutical industry.
A broad knowledge of research and development process.
Experience in cell and/or gene therapy modality is a plus.
Familiarity of regulatory guidance (e.g.
ICH, FDA, EMA) and experience in GLP studies.
A proven track record of successful IND compilation.
Exposure to working in a project/program team environment.
Excellent oral and written communication.
Able to travel (up to 10%).
LI-AL1 BlueRock Therapeutics Company Culture Highlights Winner of Comparably’s Award for Best Company for Diversity 2022Winner of Comparably’s Award for Best Company for Women 2022Winner of Comparably’s Award for Best CEO 2022BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.
Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics 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.