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Genetix Biotherapeutics · 1 month ago

Vice President, Technical Development

Somerville, MA

Contract

Hybrid

Director/Executive

$284K/yr - $378K/yr

10+ years exp

Genetix Biotherapeutics is committed to developing curative gene therapies, and they are seeking a strategic Head of Technical Development with expertise in CD34+ cell-based therapies. The role involves leading manufacturing process development, overseeing internal and external activities, and ensuring compliance with regulatory standards for commercial production.

Biotechnology

Responsibilities

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

Design and optimize process unit operations aligned with QbD principles. Demonstrate clear understanding of CQA and CPP interactions in CD34+ cell therapy processes

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

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

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

Work closely with Analytical Development, MSAT, QA, Regulatory, and Clinical to align technical strategies with overall program objectives

Build and mentor a high-performing team of scientists and engineers to drive innovation and operational excellence

Qualification

CD34+ cell therapiesBioprocess developmentComparability strategiesRegulatory expectationsClosed/automated systemsProject managementTeam buildingRisk assessmentCross-functional leadershipMentorship

Required

PhD or MS in Cell Biology, Immunology, Biomedical Engineering, or related field

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

Hands-on experience executing comparability strategies for process changes

Experienced in OOS investigations, FMEA, risk assessment, CAPA, and RCA

In-depth knowledge of regulatory expectations for comparability of late stage or commercial stage cell therapy product

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

Demonstrated ability to lead cross-functional teams and manage external partnerships

Strong leadership in CDMO management and project management capabilities