Lead HPLC/GC Method Development SME for APIs

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

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.