SENIOR SCIENTIST CMC, PROCESS DEVELOPMENT 9/16/2017
New York City, NY
JOB DESCRIPTIONAPPLY BlueRock Therapeutics is a next-generation regenerative medicine company focused on breakthrough treatments and new horizons in medicine. BlueRock Therapeutics platform is based on state of the art pluripotent stem cell engineering tools and expansion technology. The company represents a strategic partnership between Bayer and Versant Ventures, and has been granted access to one of the largest-ever Series A financings in biotech.
Our vision at BlueRock is to cure cardiovascular, neurologic and other diseases with significant unmet need and diminished self-repair potential. Our platform is enabled by strategic partnerships with leading academic and industry collaborators in the U.S., Canada and Japan.
BlueRock s ambition is to have an R&D team of dynamic and highly engaged top scientists who are inspired to take project ownership and further develop themselves in one of the most rapidly growing scientific fields. At BlueRock we value open communication, collaboration and a positive and fun working environment in which both individual and team contributions are recognized. Our world-class management team is committed to fostering the growth and career development of employees.
The New York, USA site is seeking a Senior Scientist CMC, Process Development, reporting to the Senior Director, CNS Bioprocessing.
As part of BlueRock Therapeutics vision to change the future of medicine by enabling ground-breaking cell therapies, the incumbent will be a key technical contributor of a dynamic and progressive team pioneering scaled somatic cell manufacturing processes utilizing state-of-the-art culturing technology at increasing scales. The Senior Scientist CMC will lead a team of Researchers (Chemistry, Manufacturing & Control) that optimizes Standard Operating Procedures (SOP s) for pluripotent stem cell growth and differentiation to achieve full cGMP compliance. He/she will evaluate primary and secondary vendors and work on a scalable and reliable raw material pipeline.
This is an outstanding opportunity for a talented individual to contribute to bringing a new class of medicines to patients and gain valuable career experience in translational medicine.
Develop and perform process development experiments to translate transfer of robust, efficient, and scalable cell culture processes to clinical and commercial cGMP manufacturing facilities.
Prepare and manage Standard Operating Procedures, batch records and other process documentation. Assist in preparation of CMC sections of regulatory applications.
Strategic input into the research direction by interaction with the Senior Director, CNS Bioprocessing.
Prepare and present hypotheses, on-going progress reports, technical reports and future plans (including contributing to budgets and complement plans).
Support the scientific operation of the laboratory by maintaining somatic cells in cultures at small scale (e.g. well plates) and large scale using bioreactors (stirred tank, wave bag, etc.) and supporting the process development team in upstream and downstream processes.
Analyze and document experimental data in electronic laboratory notebooks in a timely and accurate manner in accordance with the company quality management system.
Oversee IQ/OQ/PQ and related qualifications for processes and equipment in preparation for future process validation of commercial manufacturing systems.
Perform technology transfer of optimized cell manufacturing processes to cGMP-compliant manufacturing facilities within the company or to CMOs.
Attend and present corporate/scientific information at appropriate and relevant conferences and symposia.
Contribute to building a culture that embraces scientific excellence, integrity & urgency. Develops and fosters partnerships with key stakeholders. Maintains an interest in continuous learning and improvements.