Senior Analytical Chemist

Job Description:

Xseer Pharmaceuticals, a 503B outsourcing facility with four years of experience, is seeking a hands-on Senior Analytical Chemist with strong HPLC experience to join our Quality Control team.

Xseer has established its pharmaceutical manufacturing facility and analytical laboratory, including the installation and qualification of laboratory equipment, development of regulatory documentation and analytical test methods, and implementation of employee training programs. As the company continues to expand its manufacturing and laboratory operations, this position will play an important role in supporting analytical testing and product quality.

The Senior Analytical Chemist will work closely with the Associate Director of Chemistry. The primary responsibility of this position is to perform HPLC analytical method validation and accurately document all activities in accordance with current Good Manufacturing Practices (cGMP), approved procedures, and applicable regulatory requirements.

Key Responsibilities

• Perform HPLC analytical method validation for a variety of pharmaceutical compounds, including small molecules, peptides, proteins, and other applicable drug substances or products.
• Execute validation protocols and accurately document experimental procedures, calculations, results, deviations, and conclusions.
• Review chromatographic data, system suitability results, and analytical calculations for accuracy and completeness.
• Prepare and maintain laboratory records in accordance with cGMP, Good Documentation Practices, approved SOPs, and test methods.
• Communicate testing progress, technical issues, and unexpected results to the Associate Director of Chemistry.

Other Tasks May Include

• Supporting HPLC method development, optimization, verification, and troubleshooting.
• Performing Total Organic Carbon testing of the in-house water system.
• Performing Karl Fischer titration to determine moisture content in APIs or raw materials.
• Conducting osmolality and pH testing of liquid drug products.
• Performing FTIR testing for raw material identification.
• Completing daily balance and pH meter verification.
• Preparing samples, standards, reagents, buffers, and mobile phases.
• Performing routine equipment maintenance and basic troubleshooting.
• Assisting with the preparation and revision of analytical protocols, reports, test methods, SOPs, worksheets, and related laboratory documents.
• Supporting routine testing of raw materials, in-process samples, finished products, and stability samples, as needed.
• Maintaining a clean, organized, and inspection-ready laboratory environment.

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
• Minimum of three years of hands-on HPLC experience.
• Previous experience working in a pharmaceutical or similarly regulated cGMP laboratory.
• Experience with HPLC method validation is strongly preferred.
• Working knowledge of chromatographic data review, system suitability, sample preparation, and basic HPLC troubleshooting.
• Strong attention to detail and the ability to maintain accurate and complete laboratory documentation.
• Good written and verbal communication skills.
• Ability to work independently while collaborating effectively with laboratory and Quality team members.

Work Authorization and Location

• Candidates must be legally authorized to work in the United States. Employment sponsorship is not available for this position.
• This is a full-time, on-site position, Monday through Friday. Remote or hybrid work is not available.
• Relocation assistance is not provided. Candidates must reside within a reasonable commuting distance before their first day of employment.

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance