Senior BioMedical Engineer

Watertown, MA /
BioReactor Team /
Full Time
The Opportunity
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
PlateletBio is seeking an experienced BioMedical Engineer to lead our bioengineering function. The successful candidate will lead deployment of our custom bioreactor for clinical manufacturing and build next-generation scaled bioreactor modalities.

Key Responsibilities

    • Lead and build the BioEngineering function to meet goals in bioreactor and cellular therapeutic process development
    • Effectively manage team with strong organizational skills to coordinate multiple technical projects and priorities
    • Innovate, design, test, optimize and deploy scalable systems for mammalian cell processing for early- and late-phase human clinical trials. Evaluate different manufacturing modalities and incorporate into custom process equipment
    • Guide execution of mammalian cell bioreactor experiments in bench-top bioreactors and associated equipment with the goal of developing robust, scalable, and high productivity processes that produce therapeutic cells with appropriate product quality attributes to treat human diseases
    • Design and implement manufacturing solutions for high volume operations
    • Tactical and strategic leadership in cross functional collaboration with cell biology, preclinical, manufacturing and clinical teams
    • Work closely with pilot-scale clinical production facilities to ensure accurate technology transfer, successful large-scale production and associated regulatory filing activities
    • Close collaboration and relationship management of external vendors, consultants and key opinion leaders
    • Work closely with internal program management function to track and achieve milestones
    • Support IP filing and protection around novel innovations
    • Supervise and/or perform hands-on biological laboratory work, data analysis, develop and maintain technical documentation.
    • Establish and maintain communication with vendors and assist with product procurement, testing, and evaluation
    • Develop and maintain detailed technical documentation, including plans and notebook entries
    • Manage generation of technical reports containing all specs, drawings, documents, equipment, and material components

Preferred Skills and Qualifications

    • PhD in Biomedical Engineering, Bioprocess Science, Mechanical Engineering, Bio Engineering, Chemical Engineering, or related field
    • 8 years of experience in the biotechnology or pharmaceutical industry.
    • Development of single-use bioreactors or millifluidic cell culture platforms for mammalian cultures
    • Experience in leading teams developing bioreactor devices and control instruments, integration of software and automation, prototype evaluation, verification and qualification
    • Closed system aseptic bioprocessing from early systems to commercial scale technologies
    • Understanding of quality management and design control, technical reporting and regulatory filings
    • Familiarity with material chemistry and biocompatibility
    • Familiarity with equipment and component modeling with CAD software or equivalent
    • Relevant background in mammalian cell culture technology in cell therapeutics, biologics, or vaccines
    • Working knowledge of FDA guidance’s, quality management systems, design control, test method validation, and design verification
    • Excellent oral and written communication skills
The Company
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.