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

About Alliance Biotech Solutions

Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success.

Alliance Biotech Solutions is an Equal Employment Opportunity / Affirmative 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.

Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee.

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.

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ALLIANCE BIOTECH SOLUTIONS LLC

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