Pattern Biosciences
Acting as both architect and chief problem-solver, the Head of Chemistry, Manufacturing & Controls (CMC) shapes the technical dimensions of our oncology pipeline of AAV-packaged DNA computing payloads. From the time of conception of a therapeutic program, you will develop a phase-appropriate, risk-based CMC roadmap that converts scientific promise into GMP-ready product. You will build our manufacturing platform including the selection of cell lines, securing plasmid supply, configuring upstream and downstream processes and fill-finish. You will also oversee analytical development and quality control from early-stage research through clinical development and commercialization. Day-to-day, you will manage a lean internal team and a range of CDMOs, raw-material vendors and QC labs. You will author and defend CMC sections of INDs, and serve as the company’s face in FDA and other global agency interactions. As programs mature, you will drive tech transfers, process-performance qualification and cost-of-goods optimization, while instilling a culture of data integrity, electronic batch records and phase-appropriate GMP. Beyond the bench, you will translate complex technical risk into clear board-level decisions, ensuring manufacturing, supply-chain and quality strategies keep pace with aggressive growth plans. The ideal candidate will possess deep expertise in AAV manufacturing, a strong understanding of regulatory requirements for gene therapies, and a proven track record of successful CMC leadership in the biotech or pharmaceutical industry.
Primary Responsibilities
Set the CMC Vision & Roadmap Translate the product strategy into a phase-appropriate CMC plan that spans discovery hand- off through first commercial launch Define “success gates” (e.g., tox material, IND, Phase 1/2 clinical supply, Phase 3 pivotal study supply, validation batches) and align them with corporate milestones and cash runway Continuously refine the plan as new scientific, clinical or financing data emerge Lead Process & Analytical Development Evaluate and recommend new technologies and approaches to optimize manufacturing processes and analytical methods for AAV products Establish robust, scalable, and transferable processes (both “lab-scale” proof-of-concept and pilot-scale/engineering runs), either in-house or with the help of a third-party service provider Own the full analytical toolbox, either in-house or with the help of a service provider including identity, purity, potency, safety, stability, etc., and ensure that the methods mature in lockstep with the process and with the product development phase Introduce Quality-by-Design thinking early: define quality target product profile (QTPP), critical quality attributes (CQAs), critical process parameters (CPPs), design spaces, control strategies Oversee Outsourced GMP Manufacturing & Tech Transfer Evaluate and select appropriate external vendors (CDMOs, plasmid suppliers, QC labs) that align with the process and the company needs to deliver phase-appropriate GMP batches. Negotiate Master Service Agreements with these vendors Manage external vendors and ensure that tox/GLP material, clinical Phase 1/2 batches, Phase 3 batches, and PPQ/validation lots are delivered on time and on budget Draft and negotiate SOWs for outsourced projects, manage these projects on behalf of the company; manage vendor performance and forecasting; review vendor supply chains and manage supply chain risks Run and document tech transfers to partners Serve as the Regulatory CMC Architect Compose and defend all CMC sections of INDs and other regulatory submissions Lead interactions with FDA and other agencies Translate evolving ATMP guidance into actionable, risk-based internal standards Build & Coach a High-Performance Team Hire and manage scientists/engineers who can stretch across development, manufacturing and quality in the early days, then add specialists as programs mature Control Budget & External Spend Own capital-planning for internal work and equipment, develop cost-of-goods models, budget and monitor CDMO and other third party vendors work orders Regularly re-forecast against the clinical plan and investor expectations Plan for Commercial Readiness Even pre-IND, map future scale, facility footprint, validation strategy, comparability hurdles, post-approval changes and pharmacovigilance needs so there are no surprises at Phase 3
Required Skills & Qualifications
Ph.D. (or equivalent) in Biochemical Engineering, Molecular Biology, Virology or related field; MBA advantageous 5 + years in AAV CMC, demonstrable success shepherding at least one AAV product from discovery to Phase II or late stage AAV experience Expert in large-scale suspension cell based AAV manufacturing, process characterization and validation, potency assays, and stability modeling Hands-on authorship of multiple INDs; direct participation in FDA/EMA interactions Participation in FDA/EMA inspections or pre-approval inspections are considered an asset Proven ability to inspire cross-functional teams (R&D, clinical, regulatory, commercial), negotiate with CDMOs, and communicate complex CMC issues to non-experts Strategic thinker, data-driven decision maker, comfortable in fast-paced, resource-constrained start-up environments Understands the interdisciplinary nature of product development and ability to work cross functionally with a lean team wearing multiple hats.
At Pattern Bio, we design biological circuits at the intersection of synthetic biology and AI for cell-specific targeting of cancer tissue. By integrating data-driven design into every step—from DNA constructs to AAV-based delivery systems—we are building precise, rationally engineered, curative therapies. Our cohesive and driven team in South San Francisco is dedicated to curing cancer and saving lives. #J-18808-Ljbffr
Primary Responsibilities
Set the CMC Vision & Roadmap Translate the product strategy into a phase-appropriate CMC plan that spans discovery hand- off through first commercial launch Define “success gates” (e.g., tox material, IND, Phase 1/2 clinical supply, Phase 3 pivotal study supply, validation batches) and align them with corporate milestones and cash runway Continuously refine the plan as new scientific, clinical or financing data emerge Lead Process & Analytical Development Evaluate and recommend new technologies and approaches to optimize manufacturing processes and analytical methods for AAV products Establish robust, scalable, and transferable processes (both “lab-scale” proof-of-concept and pilot-scale/engineering runs), either in-house or with the help of a third-party service provider Own the full analytical toolbox, either in-house or with the help of a service provider including identity, purity, potency, safety, stability, etc., and ensure that the methods mature in lockstep with the process and with the product development phase Introduce Quality-by-Design thinking early: define quality target product profile (QTPP), critical quality attributes (CQAs), critical process parameters (CPPs), design spaces, control strategies Oversee Outsourced GMP Manufacturing & Tech Transfer Evaluate and select appropriate external vendors (CDMOs, plasmid suppliers, QC labs) that align with the process and the company needs to deliver phase-appropriate GMP batches. Negotiate Master Service Agreements with these vendors Manage external vendors and ensure that tox/GLP material, clinical Phase 1/2 batches, Phase 3 batches, and PPQ/validation lots are delivered on time and on budget Draft and negotiate SOWs for outsourced projects, manage these projects on behalf of the company; manage vendor performance and forecasting; review vendor supply chains and manage supply chain risks Run and document tech transfers to partners Serve as the Regulatory CMC Architect Compose and defend all CMC sections of INDs and other regulatory submissions Lead interactions with FDA and other agencies Translate evolving ATMP guidance into actionable, risk-based internal standards Build & Coach a High-Performance Team Hire and manage scientists/engineers who can stretch across development, manufacturing and quality in the early days, then add specialists as programs mature Control Budget & External Spend Own capital-planning for internal work and equipment, develop cost-of-goods models, budget and monitor CDMO and other third party vendors work orders Regularly re-forecast against the clinical plan and investor expectations Plan for Commercial Readiness Even pre-IND, map future scale, facility footprint, validation strategy, comparability hurdles, post-approval changes and pharmacovigilance needs so there are no surprises at Phase 3
Required Skills & Qualifications
Ph.D. (or equivalent) in Biochemical Engineering, Molecular Biology, Virology or related field; MBA advantageous 5 + years in AAV CMC, demonstrable success shepherding at least one AAV product from discovery to Phase II or late stage AAV experience Expert in large-scale suspension cell based AAV manufacturing, process characterization and validation, potency assays, and stability modeling Hands-on authorship of multiple INDs; direct participation in FDA/EMA interactions Participation in FDA/EMA inspections or pre-approval inspections are considered an asset Proven ability to inspire cross-functional teams (R&D, clinical, regulatory, commercial), negotiate with CDMOs, and communicate complex CMC issues to non-experts Strategic thinker, data-driven decision maker, comfortable in fast-paced, resource-constrained start-up environments Understands the interdisciplinary nature of product development and ability to work cross functionally with a lean team wearing multiple hats.
At Pattern Bio, we design biological circuits at the intersection of synthetic biology and AI for cell-specific targeting of cancer tissue. By integrating data-driven design into every step—from DNA constructs to AAV-based delivery systems—we are building precise, rationally engineered, curative therapies. Our cohesive and driven team in South San Francisco is dedicated to curing cancer and saving lives. #J-18808-Ljbffr