Quality Control - SME

We are seeking an experienced HPLC / GC Subject Matter Expert (SME) to support and lead analytical method development activities for a synthetic small-molecule pharmaceutical manufacturing organization
. The ideal candidate will have extensive hands-on experience developing, optimizing, qualifying, and validating chromatographic analytical methods used to support small-molecule API manufacturing and quality control operations
.

This role will work closely with Synthetic Chemistry, Process Development, Quality Control (QC), Quality Assurance (QA), Manufacturing, and other technical functions to develop fit-for-purpose analytical methods and ensure those methods are scientifically sound, robust, reproducible, and compliant with applicable GMP requirements.

The successful candidate should be comfortable functioning as a hands-on technical SME as well as a project/technical lead
, providing scientific direction, troubleshooting complex analytical problems, reviewing data, and mentoring analytical scientists.

• Lead and/or independently execute analytical method development activities for small-molecule APIs, intermediates, starting materials, process samples, and related pharmaceutical materials.
• Develop, optimize, and troubleshoot HPLC methods for assay, purity, related substances, degradation products, and other critical quality attributes.
• Provide technical expertise in GC method development for residual solvents, volatile impurities, and other applicable small-molecule analytical requirements.
• Select appropriate chromatographic conditions, including columns, mobile phases, buffers, gradients, temperatures, flow rates, injection volumes, and detection parameters
  .
• Evaluate method performance and optimize analytical methods to achieve appropriate specificity, sensitivity, accuracy, precision, resolution, and robustness
  .
• Support analytical development for synthetic chemistry and API manufacturing processes
  , including in-process testing and characterization of process intermediates.
• Develop methods capable of distinguishing starting materials, intermediates, product, process-related impurities, and degradation products
  .
• Design and execute analytical experiments to investigate and resolve chromatographic issues, unexpected peaks, poor peak shape, co-elution, carryover, sensitivity issues, and method variability
  .
• Prepare and/or review analytical method development reports, method protocols, analytical procedures, and supporting technical documentation.
• Lead or support analytical method qualification and validation activities in accordance with applicable regulatory and GMP expectations.
• Develop and execute validation/qualification protocols covering parameters such as specificity, accuracy, precision, linearity, range, detection limit, quantitation limit, robustness, and solution stability
  , as applicable.
• Evaluate validation data and prepare or review analytical method validation reports
  .
• Support method transfer activities between analytical laboratories, manufacturing sites, or QC organizations.
• Troubleshoot method transfer issues and provide technical recommendations to ensure successful implementation of analytical procedures.
• Work with QC laboratories to ensure analytical methods are practical, reproducible, and suitable for routine GMP testing
  .
• Review chromatographic data, calculations, integration, system suitability, and analytical results for scientific accuracy and compliance.
• Support investigations involving OOS, OOT, atypical results, deviations, and analytical method-related discrepancies
  .
• Provide scientific input into root-cause investigations and recommend appropriate corrective and preventive actions (CAPA) where applicable.
• Collaborate with Synthetic Chemistry and Process Development teams to understand process chemistry and determine appropriate analytical strategies.
• Provide SME guidance for analytical instrumentation, chromatographic troubleshooting, and laboratory best practices.
• Ensure analytical development and validation activities are appropriately documented and aligned with GMP, data integrity, and applicable regulatory expectations
  .
• Mentor junior and mid-level analytical scientists and provide technical guidance on method development and troubleshooting.
• Participate in technical meetings, project reviews, and cross-functional discussions as the analytical SME.
• Evaluate new analytical technologies, instrumentation, columns, and approaches that could improve analytical performance or laboratory efficiency.