<p>ABOUT US</p> <p>We are seeking a strategic and technically accomplished Head of Technical Development with deep expertise in CD34+ cell-based therapies to lead the development, optimization, and lifecycle management of manufacturing processes for our commercial pipeline. You will play a critical leadership role in defining and executing manufacturing strategy, overseeing internal and external development activities, and ensuring regulatory-compliant processes suitable for commercial production. You will also not only extensive cell therapy development experience but also proven success in leading comparability assessments to support manufacturing changes, regulatory submissions, and product lifecycle transitions for commercial-stage cell therapy products. This is a full-time hybrid position (3 days a week) in our Somerville - Assembly Row, Massachusetts office.</p> <p>RESPONSIBILITIES</p> <ul> <li>Strategic Leadership: Lead the end-to-end process development strategy for CD34+ cell therapies, including apheresis handling, enrichment, activation, transduction, culture, and formulation. Lead development efforts for life cycle management of process improvements for CD34 cell therapy product. </li><li>Process Development & Optimization: Design and optimize process unit operations aligned with QbD principles. Demonstrate clear understanding of CQA and CPP interactions in CD34+ cell therapy processes. </li><li>Comparability Strategy Execution: Lead and execute comparability strategies to support process changes, manufacturing site transfers, or raw material changes, with emphasis on regulatory expectations for commercial products. Collaborate with analytical and regulatory teams to establish meaningful acceptance criteria and data packages. Understanding of risk management strategy such as Q9(R1) Quality Risk Management. </li><li>CDMO Management: Direct technology transfer activities to CDMOs, ensuring robust and well-documented transitions. Lead interactions with contract development and manufacturing organizations to ensure alignment on scope, timelines, and quality standards. </li><li>Regulatory Support: Author and review CMC sections for FDA submissions. Represent Process Development in regulatory meetings and support responses to agency questions, with a focus on comparability packages and change management. </li><li>Cross-functional Leadership: Work closely with Analytical Development, MSAT, QA, Regulatory, and Clinical to align technical strategies with overall program objectives. </li><li>Team Building & Mentorship: Build and mentor a high-performing team of scientists and engineers to drive innovation and operational excellence. </li></ul> <p>QUALIFICATIONS</p> <ul> <li>PhD or MS in Cell Biology, Immunology, Biomedical Engineering, or related field. </li><li>10-15+ years of industry experience in bioprocess development, with at least 7 years in cell therapy, ideally involving CD34+ hematopoietic stem and progenitor cells. </li><li>Hands-on experience executing comparability strategies for process changes. </li><li>Experienced in OOS investigations, FMEA, risk assessment, CAPA, and RCA. </li><li>In-depth knowledge of regulatory expectations for comparability of late stage or commercial stage cell therapy product. </li><li>Experience with closed/automated systems (e.g., CliniMACS Plus, CliniMACS Prodigy, LOVO, Cue, Sepax). Use of control charts, regression, and statistical tools (e.g., JMP, Minitab, SIMCA) for data trending of process unit operations. </li><li>Demonstrated ability to lead cross-functional teams and manage external partnerships. Strong leadership in CDMO management and project management capabilities. </li></ul> <p>Additional Information:</p> <p>Base Salary Range: $284,000 - $378,000</p> <p>The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.</p> <p>Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter shutdown, tuition reimbursement & loan repayment assistance, paid parental leave, generous commuter subsidy, and much more.</p>