Senior Scientist-Analytical Project Lead, Global Product Development · Analytical Development

Fri, 24 Apr 2026 14:13:54 GMT
Engineering

Analytical Development · Durham, North Carolina, United States of America · hybrid

Are you ready to shape the future of medicines,pioneering technical and scientific breakthroughs that transform patient lives? We are seeking an experienced and innovative Analytical Project Lead based in Durham, North Carolina.

Our vision is to transform product design, development, and characterization to enable delivery of new medicines to patients. 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.

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.

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.

Responsibilities include, but are not limited to:

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.

Analytical strategy & 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.

Method development & 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.

Characterization & 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).

CMC & 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.

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.

Durham lab capability & technology: Champion laboratory automation for sample preparation, method execution, and data analysis under GxP control.

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.

Digital, data & 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.

Quality & governance: Ensure GxP compliance where applicable, data integrity, rigorous study design, and clear communication to governance bodies.

Minimum Qualifications:

Bachelor’s (12+ years), Master’s (6+ years), or PhD (or equivalent experience) in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related field.

Significant experience in pharmaceutical analytical science with current knowledge of regulatory CMC requirements for clinical and/or marketing applications.

Demonstrated experience in analytical development for oral solid dosage forms; additional experience with inhaled and/or parenteral products preferred.

Consistent record leading teams and/or scientific projects within a global organization and with external partners/CMOs; ability to influence cross-functional strategies.

Strong proficiency with chromatographic techniques (HPLC/UPLC; LC–MS), dissolution, and complementary methodologies; for inhaled products, familiarity with aerosol performance characterization is a plus.

Hands-on experience in method development (including use of supporting software), validation, transfer, and lifecycle management under ICH guidelines and phase-appropriate frameworks.

Experience authoring analytical CMC content for submissions and responding to regulatory queries across clinical development.

Experience working in a GMP/GxP environment; familiarity with instrument/equipment qualification, calibration, and maintenance expectations.

Excellent communication, customer management, and influencing skills; ability to operate confidently and collaboratively across global, cross-disciplinary environments.

Demonstrated ability to troubleshoot technical challenges and drive data-driven decisions.

Fundamental digital and data capability relevant to analytical development, including:

Proficiency with multivariate experimental design and basic DoE concepts for method and process understanding

Working knowledge of statistics for analytical science (e.g., regression, ANOVA, capability/variation analysis, stability trending, OOS/OOT investigation)

Practical use of ELN/CDS and statistical software (e.g., JMP or Minitab) for data analysis and reporting

Preferred Qualifications:

Strategic chromatographic and separation science leadership: define orthogonal method suites (e.g., RP, HILIC, ion exchange, SEC, SFC, CE) to secure impurity resolution and stability-indicating capability; apply LC–MS(/MS) for structure confirmation and quantitation; use multidimensional LC and targeted DoE to accelerate development and set robust specifications; harmonize methods across sites with clear comparability criteria; embed lifecycle management and coach teams through complex separations (e.g., peptides, oligonucleotides, challenging matrices).

OSD focus: Support with establishing, equipping, and optimizing OSD test equipment and processes at the Durham site.