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 this Position
BlueRock Therapeutics is seeking a Scientist I or II, Process Development to join our newly opened lab space in Cambridge, MA. If you’re a key scientific contributor looking for a unique and diverse role encompassing several elements of the manufacturing process, look no further! From process development and analytics through to clinical manufacturing, this role covers a broad scope and involvement in the process from end-to-end. This position will collaborate with the team to develop, scale up the end-to-end manufacturing process and produce the clinical supply of authentic and engineered cellular products. With exciting pipelines and tremendous potential, this is an opportunity for a talented and self-motivated scientist to contribute to bringing cutting-edge cellular therapies to patients while gaining valuable career experience in Process Development.
- Develop, optimize, scale up and tech transfer of the iPSC upstream and downstream manufacturing processes for authentic and engineered cellular products.
- Drive scientific understanding of the bioprocesses and the cellular products. Evaluate and implant new technologies to the state-of-the-art cellular therapy process.
- Act as a subject matter expert from PD to collaborate with internal or external R&D, manufacturing, assay development, regulatory and QC teams for technology or method transfer.
- Train and supervise junior staff members in supporting CMC/IND related activities, including but not limited to protocol driven studies to support process change, premanufacture pilot production and method qualification.
- Perform technology transfer of cell manufacturing processes to cGMP-compliant manufacturing facilities within the company or to CMOs.
- Prepare experimental proposals, standard operating procedures, batch records and other process and cGMP documentation.
- Prepare and present hypotheses, on-going progress reports, technical reports and future plans (including contributing to budgets and complement plans)
- Co-ordinate and interact with other functions to ensure a thorough understanding of the requirements for the manufacture of iPSCs and derivatives in a cGMP compliant manner
- Assist in preparation of CMC sections of regulatory applications
- Establish and cultivate shared team values and continuously evolve the technical strategy in response to changing demands
- Present scientific data to colleagues in group meetings, prepare and present internal and external presentations
- Advanced (PhD or MS) degree in biological engineering, chemical engineering, biological sciences, or similar with 0 – 5+ (PHD) or 9 – 13+ (MS) years’ experience in industry and/or academia.
- Hands-on experience in mammalian cell culture, ideally includes pluripotent stem cells and differentiation thereof, bioprocess development for the manufacture of cell & gene biological therapeutics.
- Proven ability to structure, plan, and execute on complex projects and programs in a fast-paced environment.
- Excellent organizational and problem-solving skills, with demonstrated ability to extend these across a team and implement efficient operational processes.
- Extremely effective communication abilities
- Experience in working collaboratively in a matrix environment is preferred.