Analytical Chemistry Consultant

Alliancebiotechsolutions; Wilson (NC); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Flexible Paid Time Off

Medical, Dental and Vision Insurance

401k plan with employer contributions

Job summary

Alliance Biotech Solutions is looking for an Analytical Chemistry SME to join their pharmaceutical manufacturing facility in Wilson, North Carolina. This role involves evaluating and remediating legacy analytical methods to meet current GMP requirements.

The ideal candidate will have a Bachelor's degree in Chemistry or a related field and at least 5 years of experience in a regulated environment. The position offers competitive compensation, flexible paid time off, and comprehensive health benefits.

Qualifications

• 5+ years of experience in Quality Control, Analytical Development, or Method Validation in a regulated GMP environment.
• Experience authoring protocols, risk assessments, and technical reports.
• Proven ability to troubleshoot analytical methods and investigate atypical results.

Responsibilities

• Evaluate and remediate legacy analytical methods and supporting documentation.
• Support method transfer and validation activities.
• Train analysts and support knowledge transfer activities.

Skills

Method validation

Analytical techniques (HPLC, UPLC, GC)

Troubleshooting analytical methods

Education

Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, or related discipline

Job description

Description

Alliance Biotech Solutions is seeking an experienced Analytical Chemistry SME to support a large-scale method transfer remediation and validation program at a pharmaceutical manufacturing facility. This role will focus on the assessment, remediation, transfer, and validation of legacy analytical methods to ensure compliance with current GMP requirements and regulatory expectations.

Requirements

• Evaluate and remediate legacy analytical methods and supporting documentation.
• Support method transfer and validation activities.
• Author protocols, risk assessments, and technical reports.
• Review historical data and identify documentation or compliance gaps.
• Troubleshoot analytical methods and support investigations.
• Train analysts and support knowledge transfer activities.
• Generate GMP documentation and final reports.
• Partner with QC and QA teams to ensure regulatory compliance.

Experience/Skills

• Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, or a related scientific discipline.
• 5+ years of experience in Quality Control, Analytical Development, or Method Validation within a pharmaceutical, biotechnology, or regulated GMP environment.
• Demonstrated experience supporting analytical method transfers, method validation, method verification, or remediation activities.
• Strong experience authoring protocols, risk assessments, investigations, technical reports, and GMP documentation.
• Experience with analytical techniques such as HPLC, UPLC, GC, ICP-MS, dissolution, UV/Vis, Karl Fischer, TOC, or similar laboratory instrumentation.
• Proven ability to troubleshoot analytical methods and investigate atypical results.

Benefits & Compensation

• Industry competitive wage as a full-time employee
• Flexible Paid Time Off
• Medical, Dental and Vision Insurance with low employee cost
• Employer paid long term and short-term disability
• 401k plan with employer contributions

Alliance Biotech Solutions is an Equal Employment Opportunity / Affidiate Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.