Watertown, MA /
Manufacturing Science and Technology Team /
This is your opportunity to join a highly driven and ambitious young company that values collaboration, respect, intellectual curiosity, and integrity in our endeavor to transform the way cell therapies are developed and to expand the field of platelet-derived therapeutics. Inspired by platelet biology, we have developed a scalable, cGMP-compliant cell culture platform to make engineered human pluripotent stem cell-derived megakaryocytes and platelets. This is an exciting time to join PBG as we further scale production for human clinical trials and leverage our platform for cell-based drug delivery opportunities.
Our Ideal Candidate
We are seeking a highly motivated manufacturing associate to join our manufacturing team within Manufacturing Science and Technology (MSAT) department. This candidate will be involved in cGMP production of Stem Cell derived Platelet Like Cells (PLC) and related processes in support of early phase clinical programs.
Roles and Responsibilities
- Responsible for performing and executing cGMP manufacturing processes in accordance with approved Batch Records and SOPs as both an operator and verifier.
- Responsible for independently drafting manufacturing documents such as Batch Records and SOPs.
- Perform all manufacturing operations in a cleanroom environment, following proper aseptic protocols for both gowning, processing, and cleanroom maintenance.
- Perform basic and specialized Cell Culture processing of human induced Pluripotent Stem Cells, hematopoietic progenitors, and megakaryocytes, utilizing 2D and 3D platforms.
- Complete additional manufacturing duties such as maintaining detailed Batch Record reports and equipment logs, preparing media, and cleanroom maintenance and monitoring.
- Coordinate when appropriate to ensure raw materials and equipment are available and functioning in order to complete all manufacturing functions.
- Collaborate with process development team for training on new manufacturing processes, as well as drafting and reviewing Batch Records and SOPs.
- Participate in improvement of manufacturing processes including owning process deviations and investigations.
- Provide samples for Quality Control testing of manufactured product and cleanroom environment.
- Research new equipment and technologies to improve manufacturing efficiencies.
- Must have scheduling flexibility to enable off hours, weekend, and holiday work rotations.
Preferred Skills and Qualifications
- 2+ years of relevant lab experience including Mammalian Cell Culture. Stem Cell experience is strongly preferred.
- 2+ years of manufacturing experience in a cGMP or clinically regulated environment.
- Knowledge of aseptic processing in a cleanroom and ISO-5 environment.
- Authorized to work in U.S. – Required.
- Highly motivated, comfortable at multitasking, able to problem solve on the fly.
- Strong organizational, communication skills.
- Must be a team player.
PlateletBio, located in Watertown, MA, is a venture-backed biotech startup that was spun out of Harvard Medical School to produce allogeneic cell therapies from engineered induced pluripotent stem cells (iPSCs).
As an equal opportunity employer, Platelet Bio does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin or veteran status. We value diversity and are committed to creating an inclusive environment for team members from all backgrounds.