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.
PI086732092533-30492-40857547
...Multiplica Talent est buscando un UX/UI Designer Mid para unirse a nuestro talentoso equipo. Esta posicin es perfecta para un profesional... ...equipo y comunicar eficazmente ideas de diseo a diferentes partes interesadas. ~ Familiaridad con la investigacin de usuarios...
...assess Client staffing requirements. Qualifications: Bachelor's degree Effective communication skills Interested in recruiting or sales Strong organizational and interpersonal skills Experience working with Microsoft Office suite High-energy...
...have completed an approved and accredited Radiology Technology program Minimum Work Experience ~ Digital Imaging and post processing... ...and geriatric. Demonstrated moderate knowledge of basic computer skills. Pay Range = $32.15 - $46.84 PI2cd8d33d1783-30492-4...
...Medical Laboratory Scientist / Medical Technologist (MLS / Med Tech) Boca Raton, West Palm Beach, Delray FL Advance Your Laboratory Career Across Three Premier South Florida Facilities If you thrive in a fast-paced clinical lab environment and take pride...
...Commercial Claims Adjuster Location: Harrisburg, PA (Onsite) Compensation: $66,000-$70,000 Base Salary + Annual Bonus Potential... ...Qualifications Minimum 1 year of claims handling or claims adjusting experience Experience handling bodily injury claims Strong...