• Partner closely with Engineering and Design to define and ship intuitive, well-crafted developer interfaces using an iterative delivery model • Contribute to and execute on the Developer Tools roadmap, aligning product initiatives with company strategy and business impact • Own features and experiments end-to-end, from discovery and specification through launch and lifecycle optimization • Engage directly with customers and partners to understand how 1Password can embed seamlessly into AI-driven and developer workflows • Translate high-level themes into actionable roadmaps, experiments, and research initiatives with increasing autonomy • Drive improvements to our infrastructure secrets strategy to ensure scalability, reliability, and performance for a growing global customer base • Accelerate the pace of shipping and learning while maintaining a high bar for quality and security • Contribute to developer evangelism efforts through content, partnerships, and participation in relevant industry events

• You’ll be responsible for the success of a major product initiative, from initial conception and customer development to growth strategy. • You’ll become the trusted resource for your product, making sure that the engineering, design, sales, and marketing have what they need to make the right trade-offs, build the right product, and grow it successfully in the market.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Associate Director, Biologics CMC Drug Product Development position is a key role responsible for conducting drug product development and manufacturing from preclinical through early and late (pivotal) clinical development to commercialization for a pipeline of novel biologics products. - Develop biologics drug product formulations, processes, and administration/delivery methods throughout program’s lifecycle (preclinical through commercialization). - Contribute to and manage biologics drug product process technical transfer to CMOs and provide oversight during manufacturing. - Develop and manage external drug product development and manufacturing capabilities and network. - Ensure compliance with FDA, cGMPs, and ICH guidelines. - Author and review technical documents and regulatory filings; support associated agency interactions and product-related inspections. - Support development and implementation of new process technologies to meet business and portfolio needs. - Remain current on trends and new technology advancements across the biopharmaceutical industry. Qualifications - Ph.D. or Master’s degree in Pharmaceutical Sciences, Chemical Engineering or relevant field. - Minimum 8+ years of relevant experience in biotech/pharma industry, with a focus on drug product development and manufacturing for therapeutic protein products. - Extensive hands‐on experience and in-depth knowledge and understanding of protein formulation development, fill-finish process engineering, and administration/delivery, with working knowledge of non-monoclonal antibody formats. - Proven ability to manage global, external vendors for development, manufacturing, and testing is essential. - Proven experience in the generation of CMC regulatory sections of IND, IMPD, BLA, and MAA filings. - Extensive familiarity with phase-appropriate cGMP requirements and FDA, EU, and ICH guidelines. - Previous success working effectively in a multidisciplinary, highly matrixed environment with ability to collaborate and drive for results. - Excellent decision-making, written and verbal communication skills. - Motivated self-starter with excellent interpersonal and organizational skills. Strong self-awareness of the impact communication and working style has on others. - Qualities of the successful candidate include collaboration, accountability, cross-functional engagement, and program management. Location This position may be remote with occasional travel to the office or hybrid/based at our corporate offices in Cambridge, MA. Compensation The salary range for this role is $160,000 - $200,000. 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. Actual base salary pay for the role may vary within the range based on several factors including, but not limited to, geographic location, candidate experience, skills, relevant education/qualifications, competencies, external market, internal equity, business needs and/or other job-related factors permitted by law. - Additional compensation/benefits include annual bonus opportunity (20% of salary), annual equity awards, medical, dental, vision, life and disability insurance, 401(K) plan with employer match, stock options, employee stock purchase plan, flexible non-accrual paid time off, paid holidays, end-of-year shut down, cell phone reimbursement, tuition reimbursement, paid parental leave. Company Description Cullinan Therapeutics (NASDAQ: CGEM) is a clinical-stage biotech company developing potential first- or best-in-class, high-impact molecules in autoimmune diseases and cancer, where exceptional scientific expertise, strategic risk-taking, and rigorous decision-making unite to improve peoples’ lives. We believe in a future where those living with autoimmune diseases and cancer spend less time managing their conditions and more time on what matters most. With deep expertise in immune modulation, Cullinan is where speed meets strategy to move profound innovations forward. But movement isn’t just about speed — it’s about meaning. Our work is fueled by curiosity, determination, and compassion. We work side by side with our partners across the life science ecosystem to channel our collective potential into improving the lives of people living with autoimmune diseases and cancer.

• Own and manage the delivery backlog for AI and automation-related product work • Write detailed user stories, functional requirements, and acceptance criteria • Break down initiatives into well-scoped epics, stories, and tasks • Support Agile ceremonies including sprint planning, refinement, reviews, and retrospectives • Partner with Engineering to clarify scope and remove blockers • Analyze and document end-to-end workflows suitable for AI-driven automation • Translate operational processes into clear, executable automation requirements • Define business rules, inputs, outputs, dependencies, and exception handling • Support AI-enabled capabilities including ingestion, reconciliation, orchestration, and GenAI assistants • Ensure workflows are well-documented and testable