Quality Control - SME

United Pharma; Oregon (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

United Pharma is seeking an experienced HPLC/GC SME to lead analytical method development for a synthetic small-molecule API manufacturing organization. The role requires hands-on expertise in developing, optimizing, qualifying, and validating chromatographic methods to support API manufacturing and QA/QC operations.

You will work closely with Synthetic Chemistry, Process Development, QC, QA, and Manufacturing to ensure methods are robust, reproducible, and GMP-compliant.

Qualifications

• Experience developing HPLC and GC methods for small-molecule APIs.
• Hands-on experience qualifying and validating methods per GMP.
• Collaboration with QC/QA, Manufacturing, and Process Development.

Responsibilities

• Lead analytical method development activities for small-molecule APIs, intermediates, starting materials, process samples, and related materials.
• Develop, optimize, and troubleshoot HPLC methods for assay, purity, and related substances.
• Provide GC method development for residual solvents and volatile impurities.
• Select chromatographic conditions including columns, mobile phases, buffers, gradients, temperatures, flow rates, injection volumes, and detection parameters.
• Evaluate method performance and optimize for specificity, sensitivity, accuracy, precision, resolution, and robustness.
• Support analytical development for synthetic chemistry and API manufacturing processes, including in-process testing.
• Design and execute analytical experiments to resolve chromatographic issues and method variability.
• Prepare and review method development reports, protocols, and procedures.
• Lead or support method qualification and validation activities per regulatory expectations.
• Develop validation/qualification protocols covering specificity, accuracy, precision, linearity, range, detection limits, robustness.

Skills

HPLC method development

GC method development

Analytical method development

Method validation

GMP compliance

Project leadership

Mentoring

Data review

Tools

HPLC

GC

Analytical instrumentation

Job description

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.

Key Responsibilities

• 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.