Current Openings

  • Company Overview

    Our mission at Sigilon Therapeutics is to develop improved treatments for chronic diseases using a novel type of therapeutic: implanted cells shielded by proprietary biomaterials from immune attack and the foreign body response (fibrosis). Treatments based on the Sigilon Therapeutics technology platform will act as responsive “living therapeutics” that can provide more natural control for diseases currently treated with intermittent injection or infusion. The company is based in Cambridge, MA. Further information can be found at www.sigilon.com


    Sigilon Therapeutics is looking for an experienced Process Development Subject Matter Expert to lead our upstream Cell Process Development team. The position reports to the Head of Process Development and will lead a technical team responsible for the development activities covering preclinical cell development through clinical manufacturing and commercial launch readiness. Key objectives are to develop robust and scalable cell manufacturing processes and transfer these processes to contract manufacturing partners. The position requires strong leadership skills, expertise in cell development and manufacturing, knowledge of CMC development practices and deliverables, and experience in supporting regulatory filings. The candidate should possess strong communications skills, the ability to successfully interface with multidisciplinary teams, resolve conflicts, make cell-related decisions, and collaborate with external partners. Mentors and coaches direct reports.

    KEY RESPONSIBILITIES

    • Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.
    • Ownership of cell development and processing activities
    • Execution of cell Process Development with a focus on cell therapy bioprocessing
    • Lead a team accountable for delivery against timelines and goals for developing upstream processes for a cell therapy product
    • Leading efforts to troubleshoot and resolve technical issues
    • Oversee the development of cell-related SOPs, batch records and training documents and tech transfer processes to manufacturing partners
    • Communicating progress to Technical Operations leadership team and Cross-functional teams
    • Support team in analyzing process data to identify trends and to evaluate and identify critical process parameters
    • Contribute to authoring, assembling, and review CMC sections of regulatory filing(s) as needed.
    • Support the investigation of exceptions and determine root causes, implement CAPAs and drive to closure. Follow-up of change control ton ensure timely implementation in line with regulatory
    • Periodically travel to CMOs, CROs and collaboration partners.

    QUALIFICATIONS

    • Strategic leader and contributor with a proven track record of successes
    • Master’s with 12-15 years experience; PhD in a scientific discipline and 8-12 years relevant experience preferred; technical leader for scientific principles and concepts
    • Significant experience with a variety of mammalian cell culture technologies and operations, cell therapy specific experience preferred, including experience with bioreactors at multiple scales
    • Strong analytical knowledge for cell-related methods including advanced characterization
    • Process Development experience with a primary focus on cell development
    • Breadth of knowledge across bioprocessing technologies, cell characterization method development, GLP/GMP experience, strongly desired
    • Strong communication skills
    • Strong leadership skills
    • Significant knowledge of biologics CMC regulations and cGMP requirements, and experience in supporting regulatory filings
    • Innovative, critical and creative thinker, unafraid to propose aggressive solutions to complex problems
    • Ability to communicate and represent group to a variety of stakeholders
    • Travel up to 30%