Analytical Chemistry Consultant

United Pharma; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

United Pharma in the United States seeks an Analytical Chemistry Consultant to provide senior advisory input, oversee analytical development and QC activities, and generate reliable data to support development decisions and manufacturing.

The role covers method development, validation, transfer, impurity analysis, and stability studies, ensuring GMP compliance and data integrity across programmes from development through commercial manufacture.

Qualifications

• Degree in analytical chemistry, pharmaceutical sciences, chemistry, or related field.
• Experience delivering analytical development and QC support for small‑molecule drugs.
• Strong knowledge of chromatography, impurity analysis, and stability‑indicating methods.
• Proven method validation and transfer experience, GMP data review, investigations.
• Ability to explain complex analytical concepts to cross‑functional teams.

Responsibilities

• Provide expert analytical development and QC advice across development programmes.
• Develop and optimise analytical methods using techniques like HPLC/GC and spectroscopy.
• Characterise process impurities and degradation products; support impurity controls.
• Support formulation and manufacturing development via API attributes and dissolution.
• Develop stability‑indicating methods and oversee stability testing.
• Plan/oversee method qualification, validation and lifecycle activities.
• Lead or support analytical method transfer to labs; review protocols and data.
• Develop/review specifications, sampling plans, testing requirements; COA input.
• Investigate out‑of‑spec results and recommend CAPAs with QA.
• Prepare/Review analytical procedures, development reports, regulatory content.

Skills

Analytical development & QC support

Senior advisory input

Chromatography knowledge

Impurity analysis

Stability-indicating method dev

Education

Degree in analytical chemistry / pharmaceutical sciences

Tools

GMP practices

ICH guidance

Job description

The Analytical Chemistry Consultant will provide expert scientific and technical support across small-molecule drug substance and drug product programmes. The role involves senior-level advisory input, oversight of analytical development and quality control activities, and generation

and review of reliable data to support development decisions, clinical supply and commercial manufacture.

Key Responsibilities:

• Provide expert analytical development and QC advice across chemical and pharmaceutical development programmes, defining testing strategies to assess identity, strength, purity and quality of APIs, intermediates and finished medicines.


• Develop and optimise analytical methods using appropriate techniques such as HPLC, GC, dissolution testing and spectroscopy, selecting sample preparation, detection approaches and operating conditions suitable for the intended use.


• Characterise and quantify process-related impurities, degradation products and residual solvents, collaborating with chemical development teams to understand impurity profiles and support appropriate process controls and specifications.


• Support formulation and manufacturing process development by assessing assay, content uniformity, dissolution, drug release and other relevant quality attributes, interpreting results to guide product and process decisions.


• Develop stability-indicating methods and oversee stability testing, interpreting degradation trends and results to support proposed storage conditions, API retest periods and finished-product shelf life.


• Plan and oversee method qualification, validation and lifecycle activities, preparing and reviewing protocols and reports to demonstrate suitability for intended use in line with development stage and applicable requirements.


• Lead or support analytical method transfer to internal and contract laboratories, reviewing transfer protocols, acceptance criteria and comparative data, and troubleshooting method performance or laboratory implementation issues.


• Develop and review specifications, sampling plans and testing requirements, assess analytical data and certificates of analysis, and provide technical input to material disposition decisions within the applicable quality system.


• Support investigation of out-of-specification and out-of-trend results, reviewing laboratory evidence, assessing potential causes and recommending appropriate corrective actions in collaboration with laboratory teams and quality assurance.


• Prepare and review analytical procedures, development reports and regulatory submission content, overseeing contract laboratory deliverables and aligning activities with GMP, data integrity principles, relevant ICH guidance and project objectives.

Requirements:

• Degree or equivalent in analytical chemistry, pharmaceutical sciences, chemistry, or a related discipline.


• Demonstrated experience delivering analytical development and QC support for small-molecule drug substances and drug products.


• Strong working knowledge of chromatography, relevant product testing, impurity analysis, and stability-indicating method development.


• Proven experience in method validation and transfer, GMP laboratory practices, data review, and investigation of atypical results.


• Comfortable operating in senior advisory or consultancy roles, with the ability to communicate complex analytical concepts clearly to multidisciplinary teams.