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CMC / FormulationPermanent Remote OK$210k–$300k/yr
Senior Director, Analytical Development
The Role: Generate:Biomedicines is seeking a Senior Director, Analytical Development to set the strategic direction and lead execution of analytical development for biologics programs in a lean, fully virtual development and manufacturing model. Reporting to the Vice President, Technical Operations, this leader will shape the future analytical operating model for Generate’s biologics portfolio, including analytical strategy, method lifecycle management, release and stability testing, specifications, comparability, external analytical operations, GMP readiness, and commercialization preparation across CDMO and contract testing partners. This leader will manage and develop a small senior team that includes leaders for Analytical Development and external testing operations, while remaining deeply engaged in critical-path execution. In Generate’s lean model, this means rolling up their sleeves and providing hands-on leadership for high-impact technical decisions, partnering with the QA team to review batch-related analytical data and GMP documentation, support investigations, deviations, OOS/OOT events, CAPAs, change controls, health authority responses, and inspection readiness. The Senior Director will serve as the senior analytical partner to CMC, Process Development, MS&T, Quality, Regulatory, Supply Chain, and external partners, ensuring protein therapeutics are supported by phase-appropriate, scientifically rigorous, inspection-ready analytical control strategies that advance key company objectives and enable late-stage development and commercialization readiness Here's how you will contribute: · Define the long-term analytical development strategy, operating model, governance structure, and external partner network required to support Generate’s biologics portfolio from candidate selection through commercialization readiness. · Lead the development and execution of analytical development and external testingstrategies for protein therapeutics from candidate selection through late-stage clinical development and commercialization readiness. · Establish phase-appropriate analytical control strategies, including method development, qualification, validation, specifications, comparability assessments, stability programs, and reference standard management. · Serve as a senior enterprise leader for analytical strategy, consulting with Technical Operations, Quality, Regulatory, CMC, and executive leadership on decisions that affect key company-level objectives. · Build and lead a high-performing analytical organization, directly managing leaders responsible for Analytical Development while fostering a culture of scientific rigor, accountability, collaboration, and quality. · Serve as Generate’s senior analytical representative with CDMOs, contract testing laboratories, and external technical partners, ensuring partner strategies, performance, and issue resolution to support program, portfolio, and company priorities. · Provide strategic, technical, and hands-on oversight of CDMOs and contract testing laboratories, ensuring timely delivery of analytical development, GMP release testing, stability testing, and lifecycle management activities. · Serve as the primary analytical representative on cross-functional CMC teams, ensuring alignment of analytical activities with development, manufacturing, regulatory, and clinical supply objectives. · Partner closely with Process Development, MS&T, Quality Assurance, Regulatory Affairs, and Supply Chain teams to ensure analytical strategies support manufacturing readiness, process understanding, product quality, and lifecycle management. · Lead analytical support for technology transfers, process changes, comparability assessments, process characterization studies, and validation readiness activities. · Review and approve critical technical and GMP documentation, including analytical methods, specifications, protocols, reports, method transfer packages, validation documentation, and regulatory submission content. · Provide hands-on leadership during manufacturing campaigns and quality events, including review of batch-related analytical data, investigations, deviations, OOS/OOT results, CAPAs, and change controls. · Lead high-impact technical and GMP issue resolution, personally engaging in critical investigations, deviations, OOS/OOT events, CAPAs, change controls, batch data review, and health authority responses where senior judgment is required. · Drive inspection readiness and ensure analytical activities are executed in accordance with global regulatory expectations, cGMP requirements, data integrity principles, and company quality standards. · Contribute to IND, BLA, IMPD, and other regulatory submissions by developing analytical strategies, reviewing submission content, and supporting health authority interactions and responses. · Establish and monitor key performance indicators for external partners, ensuring high-quality execution, right-first-time performance, timely issue resolution, and continuous improvement. · Manage departmental budgets, resource planning, and external spend to ensure efficient utilization of resources while maintaining scientific excellence and operational effectiveness. · Champion emerging analytical technologies, industry trends, and innovative approaches that strengthen Generate’s analytical capabilities and support long-term development and commercialization objectives. Leadership Responsibilities: · Build systems, operating rhythms, and decision forums that promote accountability, transparency, scientific rigor, quality, and high-impact execution across Analytical Development, Quality Control, and external partners. · Recruit, develop, and retain a high-performing, diverse team with the technical depth, leadership capability, and collaborative mindset needed to support Generate’s portfolio and future growth. · Lead and coach leaders within Analytical Development and Quality Control, empowering strong decision-making while staying personally engaged in critical technical, GMP, regulatory, and partner-related escalations. · Ensure the team understands how analytical and QC work connects to Generate’s broader strategic goals, clinical supply priorities, regulatory commitments, commercialization readiness, and patient impact. · Foster strong cross-functional collaboration across Technical Operations, CMC, Process Development, MS&T, Quality Assurance, Regulatory Affairs, Supply Chain, and external partners. · Model transparent, courageous, compassionate, and data-driven communication, especially during complex technical decisions, quality events, partner escalations, regulatory interactions, and resource tradeoff discussions. · Encourage calculated risk-taking, continuous improvement, and scientific innovation while maintaining strong compliance, inspection readiness, and patient-first decision-making. The Ideal Candidate will have: · Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Molecular Biology, Chemical Engineering, or a related scientific discipline with 15+ years of relevant industry experience; alternatively, an M.S. with significant additional relevant industry experience. · Deep expertise in analytical development and quality control for biologics, including monoclonal antibodies, recombinant proteins, fusion proteins, and other complex protein therapeutics. · Demonstrated success developing and implementing phase-appropriate analytical strategies from lead candidate selection through late-stage clinical development and commercialization readiness. · Extensive experience with analytical method development, qualification, transfer, validation, lifecycle management, and establishment of control strategies for biologic drug substances and drug products. · Strong scientific understanding of protein characterization techniques, including chromatographic, electrophoretic, spectroscopic, potency, binding, purity, size variant, charge variant, and stability-indicating methodologies. · Proven experience establishing specifications, comparability strategies, stability programs, and reference standard programs to support product development and regulatory submissions. · Demonstrated leadership experience building, mentoring, and developing high-performing analytical and quality organizations in a matrixed biotechnology or pharmaceutical environment. · Experience leading leaders and developing senior technical talent in a lean, high-accountability organization. · Significant experience managing CDMOs, contract testing laboratories, and external analytical partners within a fully outsourced development and manufacturing model. · Strong understanding of GMP requirements, data integrity principles, and quality systems, including deviations, investigations, CAPAs, change controls, OOS/OOT management, and inspection readiness. · Experience supporting technology transfers, process characterization, manufacturing investigations, process validation readiness, and lifecycle management activities in collaboration with Process Development, MS&T, and Manufacturing organizations. · Proven track record authoring, reviewing, and defending analytical and QC content for regulatory submissions, including INDs, BLAs, IMPDs, and responses to global health authorities. · Demonstrated ability to communicate complex scientific, regulatory, quality, and operational issues to executive leadership, senior cross-functional stakeholders, regulatory agencies, and external partners. · Strong business acumen with experience managing budgets, external spend, resource planning, and prioritization across multiple programs and competing timelines. · A strategic, proactive leader who can anticipate risks, develop mitigation plans, and ensure analytical and QC activities remain aligned with clinical, regulatory, commercial, and company-level objectives. · A hands-on senior leader who maintains appropriate engagement in technical and GMP execution activities while effectively empowering, developing, and holding their team accountable. · Excellent collaboration, communication, and influencing skills, with a demonstrated ability to build productive relationships across functions, organizations, and external partners Nice to Have: · A hands-on enterprise leader who is equally comfortable defining long-term analytical strategy, advising executive stakeholders, and diving into critical GMP investigations, batch-related analytical data, change controls, regulatory responses, and manufacturing support activities when the work requires senior judgment. · A strategic analytical leader who enjoys building organizations, developing leaders, and influencing complex cross-functional decisions that affect portfolio and company priorities. · A scientifically rigorous problem solver who can translate analytical data into actionable development, manufacturing, regulatory, and quality strategies. · A collaborative leader who thrives in a highly outsourced environment and enjoys building strong partnerships with CDMOs, testing laboratories, and internal stakeholders. · A resilient, proactive operator who can help a lean biotech team move quickly while maintaining strong scientific, GMP, and regulatory discipline. Who Will Love This Job: · A hands-on enterprise leader who is equally comfortable defining long-term analytical strategy, advising executive stakeholders, and diving into critical GMP investigations, batch-related analytical data, change controls, regulatory responses, and manufacturing support activities when the work requires senior judgment. · A strategic analytical leader who enjoys building organizations, developing leaders, and influencing complex cross-functional decisions that affect portfolio and company priorities. · A scientifically rigorous problem solver who can translate analytical data into actionable development, manufacturing, regulatory, and quality strategies. · A collaborative leader who thrives in a highly outsourced environment and enjoys building strong partnerships with CDMOs, testing laboratories, and internal stakeholders. · A resilient, proactive operator who can help a lean biotech team move quickly while maintaining strong scientific, GMP, and regulatory discipline. About Generate Biomedicines We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation. At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors. Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto. #LI-RT1 Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range $210,000—$300,000 USD
Tech TransferPermanent$153k–$170k/yr
Senior Manager, Operational Excellence and Process Engineering
Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company) Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer. We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us. Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day. About The Role The Senior Manager, Laboratory Systems & Process Engineering is a people and technical leadership role responsible for managing a team of Laboratory Systems Scientists while driving the implementation, optimization, and continuous improvement of laboratory systems and operational processes supporting Foresight Diagnostics’ laboratory operations. This role serves as a critical operational leader within the Operational Excellence and Process Engineering organization, bridging strategic direction from laboratory operations leadership with day-to-day execution across laboratory systems, process engineering, asset management, and technology transfer initiatives. The Senior Manager is responsible for ensuring laboratory systems and workflows are scalable, efficient, compliance, and aligned with organizational growth and business-aligned objectives. The Senior Manager partners closely with Laboratory Operations, R&D, Bioinformatics, Software Engineering, Automation Engineering, Quality, Regulatory, and Product teams to operationalize new capabilities, improve laboratory performance, and support high-throughput and high-complexity molecular testing operations. This position requires strong leadership, operational, and process engineering capabilities, along with the ability to exercise independent judgment in managing complex cross-functional initiatives and operational challenges in a regulated clinical laboratory environment. This position reports to the Director of Laboratory Operations. What You Will Do Directly manage and develop a team of Laboratory Systems Scientists responsible for laboratory systems implementation, process engineering, validation activities, and operational support. Provide coaching, mentorship, performance management, and career development to team members. Establish team priorities, allocate resources, and ensure successful execution of operational and strategic initiatives under the direction of the Director of Laboratory Operations. Lead implementation and optimization of laboratory systems including automation platforms, laboratory software solutions, assay chemistry changes, laboratory workflows, and operational infrastructure. Support operational rollout of new assays, platforms, workflows, software solutions and clinical partnerships into the clinical production environments. Partner cross-functionally to ensure successful technology transfer, user adoption, training, and operational readiness. Apply Lean principles and process engineering methodologies to improve operational efficiency, workflow reliability, throughput, and scalability. Identify process bottlenecks, operational risk, and system inefficiencies through analysis of operational and analytical performance data. Lead structured problem-solving and root cause investigations to resolve complex operational issues and implement sustainable corrective actions. Oversee execution of validation, verification, and performance qualification activities for laboratory systems, automation platforms, instrumentation/equipment, and operational workflows as assigned. Ensure laboratory systems and operational processes align with CAP, CLIA, NYSDOH, GxP and applicable regulatory requirements. Collaborate with cross functional stakeholders to define system requirements and operational priorities translating operational needs into functional requirements and scalable process solutions. Support development and monitoring of KPIs, dashboards, and operational metrics related to laboratory systems, workflow performance, quality, and throughput as assigned utilizing operational data to identify trends, evaluate system effectiveness, and drive data-informed process improvements. Support change control activities and ensure proper documentation of operational and system modifications. Serve as a senior operational and technical resource for laboratory systems and process engineering initiatives. As required, participate in internal and external audits. Other duties as assigned. What You Will Bring Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field required; advanced degree preferred. 8+ years of relevant laboratory experience in diagnostics, life sciences, or related field; advanced degree preferred. 4+ years of direct people management experience leading technical or operational teams. 3+ years of experience in regulated laboratory environments (CAP, CLIA, NYSDOH, GxP, or ISO 13485/15189). Strong expertise in laboratory systems, automation, or software integration, with demonstrated success leading cross-functional system implementation or process optimization projects. Significant experience in NGS or other complex molecular workflows with deep understanding of process development and validation. Proven ability to lead, design, execute, and document PQ, verification, and validation studies in compliance with regulatory requirements. Strong understanding of developing LIMS, digital workflow tools, equipment management systems, and laboratory informatics platforms. Expertise in systems thinking and strategic problem-solving skills, able to anticipate downstream impacts and propose scalable solutions. Excellent cross-functional collaboration skills with ability to balance scientific, technical, and business requirements. Experience supporting or leading tech transfer and process scaling initiatives in a dynamic laboratory setting. Strong written and verbal communication skills with ability to draft technical reports, SOPs, and training documentation. Demonstrated ability to manage multiple operational initiatives concurrently. Proven ability to operation effectively in fast-paced, high-growth organizations and with supporting teams through significant organizational change. A flexible, self-starter mindset with the ability to manage multiple priorities in a fast-paced startup environment. Compensation & Total Rewards This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations. This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including: Annual performance incentive bonus Long-term equity awards Comprehensive health benefits (medical, dental, vision) 401(k) with company match Generous paid time off and company holidays Additional wellness and work-life benefits Compensation Range $153,100.00 - $170,000.00 OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page
This is a demonstration marketplace. Provider, consultant, project, and review records are illustrative and unverified. Do not transact or make qualification decisions based on them.