CMC Jobs

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Associate Director of Analytical Development and CMC Statistics will provide technical and statistical leadership for analytical development, method validation, method transfer, comparability, stability, specifications, and lifecycle management activities supporting biologic drug substance and drug product programs. This role will sit within the CMC Analytical Sciences organization and will partner closely with Analytical, MSAT, Quality, Regulatory Affairs, Supply Chain, and external CDMOs/CROs to ensure that analytical strategies, statistical approaches, and data packages are scientifically robust, phase-appropriate, compliant, and suitable for global regulatory submissions and commercial readiness. The successful candidate will combine hands-on experience in biologics analytical development with strong statistical expertise, including method validation statistics, stability and shelf-life modeling, specification setting, comparability assessments, assay lifecycle monitoring, and statistical support for CMC investigations. This individual will be expected to translate complex analytical datasets into clear conclusions, support risk-based decision-making, and contribute directly to IND/IMPD, BLA/MAA, post-approval, and health authority response activities. Role and Responsibilities: Provide scientific and technical leadership for analytical method development, qualification, validation, transfer, troubleshooting, and lifecycle management for biologic drug substance and drug product programs. Support phase-appropriate analytical strategies for release, stability, characterization, comparability, potency, binding, impurity, and residual testing. Review and interpret analytical data from CDMOs, CROs, and partner laboratories to ensure methods are robust, fit for purpose, and aligned with regulatory expectations. Contribute to analytical control strategy development, including critical quality attribute assessment, method performance monitoring, and product quality trend evaluation. Lead statistical planning, analysis, and interpretation for analytical method validation, method transfer, comparability, stability, specification setting, assay qualification, and investigation support. Apply appropriate statistical tools to evaluate accuracy, precision, linearity, range, robustness, intermediate precision, equivalence, trending, outliers, assay variability, and method capability. Develop and justify statistically sound acceptance criteria, comparability criteria, stability models, DS and DP shelf-life determinations, stability trending approaches, and analytical control limits. Partner with CMC, Quality, Regulatory Affairs, and external partners to ensure statistical approaches are scientifically defensible and clearly documented in protocols, reports, and regulatory submissions. Support data visualization, multivariate analysis, and trend monitoring to enable early identification of analytical or manufacturing risks. Support inspection readiness, audit responses, regulatory commitments, and post-approval lifecycle management activities related to analytical methods, stability, specifications, and comparability. Provide statistical input into deviations, OOS/OOT investigations, CAPAs, change controls, and risk assessments. Provide analytical and statistical oversight for external CDMOs, CROs, and partner laboratories performing release, stability, characterization, method transfer, method validation, and comparability studies. Review external protocols, reports, data packages, deviations, and investigations to ensure technical quality, compliance, and alignment with program objectives. Communicate complex analytical and statistical findings clearly to technical and non-technical stakeholders, including senior leadership. Contribute to internal SOPs, templates, best practices, and governance processes for analytical development, CMC statistics, and outsourced analytical activities. All other duties as assigned. Experience, Education and Specialized Knowledge and Skills: Advanced degree(s) preferred in Statistics, Biostatistics, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline; Bachelor’s or master’s degree with substantial relevant experience will be considered. Minimum of 10+ years of relevant experience in the biopharmaceutical or pharmaceutical industry, including direct experience supporting CMC analytical development and/or process development and manufacturing activities. Strong knowledge and understanding of biologics analytical methods, including chromatographic, electrophoretic, immunoassay, potency, binding, impurity, and/or process residuals. Demonstrated experience with analytical method development, validation, method transfer, comparability, specification setting, stability analysis, and statistical analysis & interpretation of CMC datasets. Working knowledge of ICH, FDA and EMA guidance and GMP regulation, as well as data integrity expectations relevant to analytical development and lifecycle management. Experience reviewing or authoring protocols, reports, regulatory submission sections, health authority responses, deviations, OOS/OOT investigations, CAPAs, and change controls. Travel may be required periodically to support CDMO/CRO oversight, technical meetings, regulatory interactions, or cross-functional workshops. This is the pay for this position Pay Transparency $180,000 — $200,000 USD Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Title: Director, Pharmaceutical Development Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease. Position Nurix Therapeutics, Inc. is seeking a highly experienced Director of Pharmaceutical Development. The role leads small molecule drug product development focused on oral and topical dosage forms. Responsibilities span QbD-based formulation and process development from early phase through commercial launch. The position requires strong cross-functional collaboration and hands-on CDMO management. This position is on site in the Brisbane, CA office. Responsibilities Formulation & Process Development Lead QbD-based formulation and process development for small molecule drug programs with a focus on oral and topical dosage forms across all development phases. Apply expertise in BCS Class II/IV compound development and enabling formulation technologies, including amorphous solid dispersions (spray-dried dispersions, hot-melt extrusion), lipid-based drug delivery systems (SMEDDS, SEDDS, lipid suspensions), and nano-formulations to address solubility and bioavailability challenges. Define and document the Quality Target Product Profile (QTPP) and identify Critical Quality Attributes (CQAs) to guide formulation strategy. Conduct systematic risk assessments to identify Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) using FMEA and other risk assessment tools. Develop and optimize manufacturing processes appropriate to the dosage form, ensuring scalability and process robustness. Scale-Up & Technology Transfer Lead manufacturing scale-up activities from laboratory to pilot and commercial scale, ensuring robust and reproducible processes. Troubleshoot manufacturing deviations, out-of-specification results, and process failures; drive root cause analysis and implement corrective actions. Late-Stage Development & Regulatory Drive late-stage development activities (Phase 2b through commercial launch) including clinical supply manufacturing, process performance qualification (PPQ), and continued process verification (CPV). Author and review CMC sections of regulatory submissions including INDs, NDAs, and MAAs. Ensure all development activities comply with current GMP regulations and internal quality standards. CDMO Management & Cross-Functional Leadership Manage external CDMO partnerships, including vendor qualification, technical oversight, and performance governance to ensure project timelines, quality standards, and budget commitments are met. Serve as the primary technical point of contact between pharmaceutical development and cross-functional teams including Analytical Development, Clinical Operations, Regulatory Affairs, Quality, Supply Chain, and Commercial. Provide scientific leadership and mentorship to junior scientists, associates, and project team members. Requirements Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or a closely related discipline strongly preferred with 12 years of industry experience. 12+ years of progressive pharmaceutical development experience in an industry setting (biotechnology, pharmaceutical, or CDMO). Deep expertise in small molecule drug product development with a focus on oral and topical dosage forms, especially enabled formulation development (e.g., amorphous solid dispersions, lipid-based systems, nano-formulations). Comprehensive hands-on experience with QbD methodologies: QTPP definition, CQA identification, CMA/CPP risk assessment, DoE, design space development, and control strategy establishment. Significant late-stage development experience (Phase 2b/3 and NDA/MAA submission) is required. Proven track record of authoring and/or reviewing CMC regulatory submissions (INDs, NDAs, CTDs) and successfully responding to agency queries. Direct CDMO management experience, including technical oversight, project governance, and relationship management. Knowledge of lifecycle management, post-approval changes, and SUPAC guidance. For the Director level: demonstrated people management experience leading a team of scientists/managers, department-level strategic planning, and budget/resource ownership across multiple concurrent programs. Primarily office and laboratory environment; occasional GMP manufacturing facility access required. Approximately 25% travel required, including domestic and international trips to CDMO sites, clinical manufacturing sites, regulatory agency meetings, and scientific conferences. Must be able to gown for cleanroom/GMP environments Core Competencies Scientific Leadership — Recognized internal and external thought leader in pharmaceutical development; drives scientific innovation and excellence. Strategic Thinking — Ability to anticipate technical and regulatory risks and develop proactive mitigation strategies that protect project timelines. Cross-Functional Collaboration — Demonstrated ability to build strong working relationships and influence without authority across diverse internal and external stakeholders. Project Management — Experienced in managing multiple complex projects simultaneously in a fast-paced, deadline-driven environment. Communication — Exceptional written and verbal communication skills; able to present complex scientific data clearly to both technical and non-technical audiences, including senior leadership and regulatory agencies. People Development — Commitment to mentoring and developing scientific talent within the organization. Salary Range: 218K – 260K plus bonus and equity. Fit with Nurix Culture and Values Strong team orientation; highly collaborative Solutions and results-oriented focus Hands-on approach; resourceful and open to diverse points of view Application Process Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US. Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy ( https://www.nurixtx.com/privacy-policy/ ).