What are the responsibilities and job description for the Analytical Development Scientist position at AL Solutions?
Contractor – Analytical Development Scientist
Separation-Based Assays & GMP Documentation Support
Bristol, PA (Fully Onsite)
Weekend Shift Pattern: Three 12-Hour Shifts
Contract through year-end with extension throughout next year - W2 available
Join a Growing Analytical Development Team
Our client, a leading biopharmaceutical organization, is seeking an experienced Analytical Development Scientist to support critical analytical development and GMP documentation activities. This is an excellent opportunity for a scientist with strong separation sciences expertise and a passion for data quality, compliance, and analytical excellence.
Working closely with Analytical Development leadership, you will play a key role in reviewing laboratory documentation, supporting analytical method activities, and ensuring development data meets the highest standards of GMP compliance and regulatory integrity.
Please note: This role follows a weekend schedule of three 12-hour shifts, and candidates must be comfortable committing to this work pattern.
Key Responsibilities
As the Analytical Development Scientist, you will:
- Review analytical development laboratory notebooks for GDP compliance, completeness, accuracy, and data integrity.
- Evaluate analytical methods and supporting data to ensure suitability for development objectives.
- Provide technical expertise across separation-based analytical platforms including:
- HPLC / UPLC
- Reverse Phase (RP-HPLC)
- Ion Exchange Chromatography (IEX)
- Size Exclusion Chromatography (SEC)
- Hydrophobic Interaction Chromatography (HIC)
- Gas Chromatography (GC)
- CE-SDS
- cIEF
- Review analytical methods to ensure compliance with GMP and internal quality standards.
- Support qualification, validation, and transfer of analytical methods into QC environments.
- Review qualification protocols, reports, and analytical development documentation.
- Assist with preparation and review of development reports.
- Review and contribute to Certificates of Testing (CoT) for development batch release and stability programs.
- Support analytical investigations, chromatography troubleshooting, and system suitability assessments.
- Ensure all documentation meets regulatory, GMP, GDP, and data integrity requirements.
What We're Looking For
Required Qualifications
- Bachelor's degree or higher in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline.
- 4 years' experience in Analytical Development or Quality Control within a GMP-regulated pharmaceutical, biologics, or biotechnology environment.
- Strong hands-on experience with HPLC/UPLC methodologies.
- Experience reviewing analytical data, chromatograms, laboratory notebooks, protocols, and technical reports.
- Working knowledge of GMP, GDP, and data integrity requirements.
- Experience supporting method development, optimisation, qualification, validation, or transfer activities.
- Strong attention to detail with excellent written and verbal communication skills.
Preferred Experience
- Biologics, protein, antibody, vaccine, or conjugate analytical experience.
- CE-SDS, cIEF, SEC, RP-HPLC, IEX, and Empower software experience.
- Stability testing and regulatory support activities.
- Understanding of ICH guidelines, including analytical method validation and stability studies.
- Experience generating analytical data packages supporting IND-enabling programs.
- Prior IND filing support experience.
- Knowledge of specification setting, analytical trending, and stability data interpretation.
Don't tick every box? We'd still love to hear from you. Strong analytical scientists from small molecule pharmaceutical environments with solid GMP experience and advanced chromatography expertise are encouraged to apply.
What's on Offer
✅ Competitive rates
✅ W2 employment options available
✅ Bi-weekly pay
✅ Medical, dental, vision, and life insurance benefits
✅ Long-term contract potential through next year
✅ Opportunity to support innovative pharmaceutical and biotechnology programs
Please note: This is an hourly contract position and therefore does not include PTO.
Apply Today
If you have strong analytical development or QC experience, a passion for chromatography and GMP compliance, and are comfortable working a weekend schedule of three 12-hour onsite shifts in Bristol, PA, we'd like to hear from you.