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In this role, you will lead analytical strategy and delivery for oral solid dosage (OSD) forms and, as needed, inhaled and/or parenteral products from early development through clinical supply and toward commercialization.</p>\n<p>As the analytical project/skill lead, you will partner across formulation, engineering, biopharmaceutics, manufacturing, QA and Regulatory to deliver robust methods, efficient control strategies, and submission-ready documentation. You will also help establish and optimize OSD laboratory capabilities at the Durham site, champion laboratory automation, and encourage adoption of modern data analytics and AI/ML tools to accelerate development and interpretation.</p>\n<p>We work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility.</p>\n<p>Responsibilities include, but are not limited to:</p>\n<ul>\n<li>Project leadership: Act as analytical skill lead to secure major drug product deliveries, applying a risk-based, flexible approach to prioritization, resources, and timelines across modalities and dosage forms; integrate analytical plans with global teams and external partners/CMOs.</li>\n</ul>\n<ul>\n<li>Analytical strategy &amp; control: Define and own a phase-appropriate analytical control strategy aligned with CMC expectations across clinical phases; harmonize methods and embed lifecycle management to ensure robust, efficient control.</li>\n</ul>\n<ul>\n<li>Method development &amp; validation: Design, develop, validate, transfer, and lifecycle manage analytical methods for OSD (e.g., HPLC/UPLC, LC–MS, dissolution, impurity profiling, stability-indicating capability); establish scientifically supported system suitability, specifications, and fit-for-purpose sample preparation; ensure readiness for GMP execution with clear documentation and analyst guidance. Support inhaled and/or parenteral methods as needed.</li>\n</ul>\n<ul>\n<li>Characterization &amp; performance: Lead drug product characterization, comparability, and stability programs; direct forced degradation studies; for inhaled products where required, support aerodynamic performance assessments (e.g., impactor analysis).</li>\n</ul>\n<ul>\n<li>CMC &amp; regulatory: Author and review analytical CMC content for IND/IMPD/NDA/MAA; prepare validation reports, method transfer documents, and specifications; lead responses to regulatory queries and support shelf life assignment with appropriate statistics.</li>\n</ul>\n<ul>\n<li>Cross-functional collaboration: Work closely with formulators, engineers, supply and manufacturing sites, QA, Regulatory, and external partners/CMOs to integrate analytical deliverables into project plans and clinical manufacturing.</li>\n</ul>\n<ul>\n<li>Durham lab capability &amp; technology: Champion laboratory automation for sample preparation, method execution, and data analysis under GxP control.</li>\n</ul>\n<ul>\n<li>Problem-solving: Lead complex investigations, root cause analyses, and data integrity assessments; apply structured problem-solving (e.g., Six Sigma) and statistics to drive timely resolution and preventive actions.</li>\n</ul>\n<ul>\n<li>Digital, data &amp; innovation: Apply DoE and statistics for method robustness and understanding; use ELN/CDS and statistical tools; promote AI/ML, chemometrics, and predictive analytics to enhance interpretation, specification setting, and development speed; enable learning and standardization across projects; chip in to patenting and/or publishing.</li>\n</ul>\n<ul>\n<li>Quality &amp; governance: Ensure GxP compliance where applicable, data integrity, rigorous study design, and clear communication to governance bodies.</li>\n</ul>\n<p>Minimum Qualifications:</p>\n<ul>\n<li>Bachelor’s (12+ years), Master’s (6+ years), or PhD (or equivalent experience) in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related field.</li>\n</ul>\n<ul>\n<li>Significant experience in pharmaceutical analytical science with current knowledge of regulatory CMC requirements for clinical and/or marketing applications.</li>\n</ul>\n<ul>\n<li>Demonstrated experience in analytical development for oral solid dosage forms; additional experience with inhaled and/or parenteral products preferred.</li>\n</ul>\n<ul>\n<li>Consistent record leading teams and/or scientific projects within a global organization and with external partners/CMOs; ability to influence cross-functional strategies.</li>\n</ul>\n<ul>\n<li>Strong proficiency with chromatographic techniques (HPLC/UPLC; LC–MS), dissolution, and complementary methodologies; for inhaled products, familiarity with aerosol performance characterization is a plus.</li>\n</ul>\n<ul>\n<li>Hands-on experience in method development (including use of supporting software), validation, transfer, and lifecycle management under ICH guidelines and phase-appropriate frameworks.</li>\n</ul>\n<ul>\n<li>Experience authoring analytical CMC content for submissions and responding to regulatory queries across clinical development.</li>\n</ul>\n<ul>\n<li>Experience working in a GMP/GxP environment; familiarity with instrument/equipment qualification, calibration, and maintenance expectations.</li>\n</ul>\n<ul>\n<li>Excellent communication, customer management, and influencing skills; 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We invest deeply in building and scaling data sources to train and evaluate our models for maximal performance. At the same time, careful validation in orthogonal, translationally-relevant assays is crucial to orient our models.</p>\n<p>We are seeking a senior scientific leader versed in high-throughput and translational biology to drive the continued growth and impact of our Palo Alto Lab. You will be a force multiplier for our scientists and engineers, ensuring a high standard of scientific rigor and output in a fast-paced, dynamic environment. You will also interface closely with our AI team to maximize the impact of internal data on Inceptive’s foundation models.</p>\n<p>Your Mission, should you choose to accept it - Lead development and scale-up of high-throughput assays across in vitro, cellular, and in vivo systems, leveraging multiplexed assays and laboratory automation - Define and execute a lab strategy aligned with Inceptive’s therapeutic and platform priorities, while remaining flexible as modality and partnership needs evolve - Champion an interdisciplinary culture, encouraging curiosity, rigor, and collaboration across scientific boundaries - Manage, mentor, and develop a multidisciplinary team of scientists and engineers that rapidly generates high-impact biological data to improve and validate AI design models - Oversee the development of industry-standard validation assays to keep models and data generation aligned with downstream therapeutic application</p>\n<p>Qualifications - PhD and 6+ years of post-PhD experience in industrial research applied to drug development - Experience managing and mentoring a data-driven lab of 10+ scientists - Experience using high-throughput and/or highly multiplexed assays to generate rich datasets from mammalian cells - Proven ability to set scientific direction while also executing operationally - Deep understanding of theory, techniques, and experimental design in molecular and cellular biology - Visualization, analysis, and statistics applied to complex biological datasets - Availability to work with team members across US and Europe, with meetings starting at 7am PT - Readiness to travel several times a year for company retreats and business events - We value in-person collaboration and expect candidates to work at our lab location</p>\n<p>Preferred skills - Translational experience with mRNA, oligonucleotides, or other genetic medicines - Expertise in immunology and/or cell therapy - Hands-on experience in RNA biology and biochemistry - Scientific programming in Python - Hands-on experience with modern data engineering workflows</p>\n<p>Compensation $245K – $305K + Bonus + Equity</p>\n<p>What we offer - A competitive compensation package - 30 days paid vacation per year - Comprehensive health insurance for US based Beginners - 401K with company match for US based Beginners and Direktversicherung for German Beginners - Quarterly company-wide retreats - Monthly wellness benefit - Budget for multiple visits per year to our offices in Berlin, Palo Alto or Switzerland - Learning &amp; Development budget to attend conferences, take courses, or otherwise invest in your professional growth, as well as access to the Learning &amp; Development platform EdX and Hone - A buddy to help you get settled *Varies by country and does not apply to internships</p>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_cf82e408-47b","directApply":true,"hiringOrganization":{"@type":"Organization","name":"Inceptive","sameAs":"https://inceptive.com","logo":"https://logos.yubhub.co/inceptive.com.png"},"x-apply-url":"https://job-boards.greenhouse.io/inceptive/jobs/5060348007","x-work-arrangement":"onsite","x-experience-level":"senior","x-job-type":"full-time","x-salary-range":"$245K – $305K + Bonus + Equity","x-skills-required":["high-throughput and translational biology","AI model development","data science","molecular and cellular biology","experimental design"],"x-skills-preferred":["translational experience with mRNA, oligonucleotides, or other genetic medicines","expertise in immunology and/or cell therapy","hands-on experience in RNA biology and biochemistry","scientific programming in Python","hands-on experience with modern data engineering workflows"],"datePosted":"2026-04-18T15:57:27.652Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Palo Alto, CA"}},"employmentType":"FULL_TIME","occupationalCategory":"Engineering","industry":"Biotechnology","skills":"high-throughput and translational biology, AI model development, data science, molecular and cellular biology, experimental design, translational experience with mRNA, oligonucleotides, or other genetic medicines, expertise in immunology and/or cell therapy, hands-on experience in RNA biology and biochemistry, scientific programming in Python, hands-on experience with modern data engineering workflows","baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":245000,"maxValue":305000,"unitText":"YEAR"}}}]}