Manager/Senior Manager, Regulatory CMC

Watertown, MA /
Regulatory CMC /
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 PlateletBio 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 Manager/Senior Manager to lead the Regulatory CMC strategy development and submission preparation for PlateletBio’s pipeline of autoimmune programs.  The Manager/Senior Manager will be instrumental in providing Regulatory CMC guidance to project teams and helping to steer novel allogeneic stem cell-derived platelet products to approval for treatment of autoimmune conditions.

Duties and Responsibilities

    • Regulatory CMC representative in cross-functional project teams providing regulatory CMC guidance and direction.
    • Develops and implements global regulatory CMC strategies across all programs from early phase submissions to marketing applications.
    • Defines, authors, and coordinates the CMC content and ensures the timely preparation of pre-IND submissions, original IND/CTA submissions, amendments, and responses to the FDA/Health Authorities.
    • Assesses CMC change controls and evaluates the regulatory risks and actions required for regulatory reporting.
    • Provides relevant guidance and advice on regulatory CMC matters to internal teams and stakeholders to assure compliance with applicable regulations.
    • Knowledgeable on current FDA/ICH CMC guidances and identifies potential regulatory CMC risks in accordance with phase appropriate regulatory expectations.
    • Leads discussion on regulatory CMC topics with internal colleagues and external partners.
    • Identifies regulatory CMC gaps and works with the CMC team to develop solutions.

Preferred Skills and Qualifications

    • BA/BS in a scientific discipline with 5+ years of regulatory CMC experience, advanced degrees preferred.  Prior experience with biologics/cell therapy products is preferred.
    • Regulatory CMC professional with strong knowledge of cGMP requirements, FDA/ICH CMC guidances, and current industry standards for FDA/Health Authority submissions.
    • Expertise in ICH CTD structure and prior experience authoring IND/CTA Module 3 sections for FDA/Health Authority submissions.
    • Strong organizational and project management skills with demonstrated success working within cross-functional teams.
    • Proficiency with Microsoft Word, Excel, and Powerpoint, and familiarity with electronic submission requirements.
    • Excellent written and verbal communication skills required.
    • Authorized to work in the U.S
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.