22 Aug
|
Sai Life Sciences
|
Hyderabad
22 Aug
Sai Life Sciences
Hyderabad
Position Title: ARD Characterization Leader NMR Expert
Function: Analytical Research and Development / Molecular Characterization
Location: Hyderabad, Telangana
Reporting To: Head of Analytical R&D; / Characterization Sciences
Role Summary The ARD Characterization Leader NMR Expert will provide scientific and technical leadership for nuclear magnetic resonance spectroscopy-based characterization across a diverse portfolio, including small molecules, peptides, antibody-drug conjugates, oligonucleotides, linkers, impurities, intermediates, and related complex modalities. The role is responsible for designing, executing, interpreting, and reviewing advanced one-dimensional and two-dimensional NMR experiments to support structure elucidation, identity confirmation, impurity characterization, quantitative analysis, method development, regulatory submissions, and project decision-making.
Key Responsibilities
- Lead NMR characterization strategies for small molecules, peptides, ADC payloads, linkers, oligonucleotides, impurities, degradation products, intermediates, and reference standards.
- Design and execute fit-for-purpose NMR experiments including 1D proton, carbon, phosphorus, fluorine, and other relevant nuclei based on molecule class and project need.
- Apply advanced 2D NMR techniques such as COSY, TOCSY, HSQC, HMBC, NOESY, ROESY, DOSY, J-resolved, HSQC-TOCSY, and selective experiments for structural assignment and connectivity confirmation.
- Interpret complex NMR datasets to support stereochemical assignment, sequence confirmation, conformational analysis, site-specific modification assessment, impurity identification, and structure confirmation.
- Develop, optimize, qualify, and validate NMR methods, including quantitative NMR approaches, in alignment with scientific, quality, and regulatory expectations.
- Provide expert review of NMR reports, analytical data packages, method documents, investigation summaries, and regulatory-supporting characterization documents.
- Collaborate with process chemistry, peptide chemistry, oligonucleotide chemistry, biologics, ADC, quality control, regulatory, and manufacturing teams to resolve analytical and structural challenges.
- Lead troubleshooting of challenging samples, low-solubility materials, mixtures, labile compounds, conjugated systems, and complex impurity profiles.
- Ensure laboratory operations comply with GLP, GMP, data integrity, safety, and internal quality standards.
- Mentor scientists and build technical capability in NMR acquisition, processing, interpretation, documentation, and scientific communication.
Required Expertise
- Deep hands-on expertise in solution-state NMR spectroscopy for pharmaceutical and biopharmaceutical characterization.
- Robust command of 2D NMR experiment selection, parameter optimization, spectral processing, peak assignment, and interpretation for complex structures.
- Demonstrated experience with characterization of small molecules, APIs, impurities, peptides, peptide conjugates, oligonucleotides, ADC-related payloads, linkers, and linker-payload intermediates.
- Experience supporting structure elucidation, impurity profiling, reference standard qualification, reaction monitoring, forced degradation studies, stability studies, and comparability assessments.
- Knowledge of complementary analytical techniques such as LC-MS, HRMS, HPLC/UPLC, ion chromatography, UV, FTIR, circular dichroism, and orthogonal impurity characterization approaches.
- Understanding of ICH expectations, analytical method validation, data integrity principles, and documentation standards for regulated pharmaceutical development.
Qualifications and Experience
- Ph.D. in Chemistry, Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a closely related discipline is required; specialization in NMR spectroscopy is strongly preferred.
- More than 20 years of relevant experience in Analytical R&D;, structural characterization, pharmaceutical development, or a regulated NMR laboratory,
with demonstrated expertise in complex molecular characterization.
- Proven record of leading complex characterization projects and providing scientific direction to cross-functional teams.
- Demonstrated experience leading and managing a multidisciplinary team of approximately 20 scientists, including workload planning, capability development, performance guidance, and delivery of project commitments.
- Experience in instrument operation, maintenance coordination, probe selection, calibration, qualification, and troubleshooting of high-field NMR systems.
- Demonstrated ability to prepare high-quality technical reports, regulatory-ready documents, and clear scientific presentations for internal and external stakeholders.
Leadership and Behavioural Competencies
- Scientific leadership with the ability to define characterization strategy and influence project decisions.
- Strong problem-solving mindset for complex molecular characterization and impurity investigations.
- Excellent collaboration skills across chemistry, biology, analytical, quality, manufacturing, and regulatory teams.
- Ability to mentor, coach, and develop a large scientific team-mid-level, and junior scientists, in advanced NMR methods and analytical characterization practices.
- Clear written and verbal communication skills, with the ability to translate complex NMR findings into actionable project recommendations.
- Commitment to quality, safety, compliance, continuous improvement, and scientific excellence.
Preferred Capabilities
- Experience with quantitative NMR method development and validation for assay, purity, and content determination.
- Exposure to solid-state NMR, diffusion NMR, variable-temperature NMR, kinetics studies, and conformational analysis is advantageous.
- Experience supporting ADC, peptide, or oligonucleotide CMC programs from early development through regulatory filing is preferred.
- Familiarity with electronic laboratory notebooks, chromatography data systems, NMR processing software, and quality management systems.
- Ability to evaluate emerging NMR technologies and introduce improved workflows, automation, and data interpretation practices.
📌 AR&D Characterization Leader - NMR Expert (Hyderabad)
🏢 Sai Life Sciences
📍 Hyderabad