Analytical Development Scientist (3-Month Contract)

Analytical Development Scientist (3-Month Contract) | GMP | Onsite

I’m currently partnered with a leading biologics CDMO who are continuing to scale their Analytical Development and GMP manufacturing capabilities across the US.

As part of this growth, they are looking to bring on an Analytical Development Contractor with a strong focus on Separation-Based Assays & GMP Documentation Support.

This position will play a key role in supporting Analytical Development by ensuring data integrity, documentation quality, and method suitability for GMP manufacturing and release. You’ll work closely with AD leadership and cross-functional teams to review analytical data, support method readiness and contribute to development batch release activities.

Responsibilities:

• Review laboratory notebooks for GDP compliance, accuracy, and completeness
• Assess analytical data and method suitability to support development programs
• Provide technical support across separation-based techniques (HPLC, GC, CE-SDS)
• Review analytical methods, protocols, and reports in line with GMP requirements
• Support method qualification activities for transfer to QC
• Contribute to development reports and technical documentation
• Review and support generation of Certificates of Testing (CoT)
• Ensure all data and documentation meet regulatory and internal compliance standards

Requirements:

• 5+ years’ experience in Analytical Development or QC within a GMP environment
• Strong expertise in separation-based techniques (HPLC, GC, CE-SDS)
• Experience reviewing lab notebooks, methods, and technical documentation
• Solid understanding of GMP and Good Documentation Practices (GDP)
• Familiarity with method development, qualification, and transfer
• Strong attention to detail and ability to manage multiple priorities
• Confident communicator with cross-functional collaboration experience

Nice to Have:

• Experience with stability studies and ICH guidelines (Q1A–Q1E, Q2, Q3)
• Exposure to early-phase development and IND-enabling activities
• Experience supporting regulatory submissions or data packages

Why This Role?

• Join a CDMO scaling rapidly toward commercial readiness
• Play a key role in bridging Analytical Development and GMP manufacturing
• High-impact position supporting real-time program delivery
• Fast-moving process with strong likelihood of extension

If this sounds interesting, feel free to apply or message George Higginson directly for a confidential discussion.