Analytical Services Contractor

We are seeking a highly skilled and detail-oriented Analytical Services Contractor to support our Analytical Serviceswith documentation and data review activities. The ideal candidate will possess strong technical expertise in separation-based analytical techniques (e.g., HPLC, GC, CE-SDS) and have a solid understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

This individual will play a critical role in reviewing laboratory notebooks, ensuring data integrity, assessing suitability of the methods with AD management oversight, and supporting GMP-related documentation including method reviews, protocol/report reviews, and Certificates of Testing (CoT) for development batches.

Qualifications

• Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• 5+ years of industry experience in analytical development or quality control within a regulated (GMP) biopharmaceutical or pharmaceutical environment.
• Strong working knowledge of separation-based analytical techniques, particularly HPLC, GC, and CE-SDS.
• Demonstrated experience in reviewing laboratory notebooks, technical reports, and GMP documents.
• Familiarity with method development and qualification principles.
• Excellent attention to detail, strong organizational skills, and the ability to manage multiple priorities.
• Effective communication and collaboration skills for cross-functional teamwork.
• Proficiency in document management systems is a plus.

Preferred Skills:

• Experience with stability testing and strong familiarity with ICH guidelines, including but not limited to: ICH Q1A-Q1E (Stability), ICH Q2(R2) (Analytical Method Validation), ICH Q3A/B (Impurities in Drug Substances and Products)
• Solid understanding of regulatory expectations for early-phase clinical development, including appropriate analytical data packages to support IND-enabling studies.
• Prior experience supporting IND filings is a plus.
• Familiarity with analytical data trending, specification setting, and interpretation of development and stability data in alignment with regulatory and internal standards.