Overview In this role you drive the development, validation, transfer, and maintenance of analytical methods to ensure accurate, compliant testing across materials and products. You will work closely with Quality Control, Quality Assurance, Manufacturing, and external labs to uphold regulatory standards and method performance. You'll address method performance issues, support investigations, and contribute to continuous improvement of analytical science. This position combines technical leadership with cross-functional collaboration in a GMP environment, aligned to Croda's quality-driven mission.
Compensation / Benefits- Medical, Dental, and Vision coverage
- Generous PTO
- 401(k) match
- Wellness reimbursement
- Parental leave
- Career development
Responsibilities- Develop, validate, verify, and maintain analytical methods per ICH, USP, FDA, EMA and applicable regulations
- Execute method development/validation studies for chemical, biochemical, and biological analyses
- Assist with validation and transfer protocols, reports, and supporting docs
- Perform analytical testing to assess accuracy, precision, linearity, specificity, range, LOD/LOQ
- Support troubleshooting, optimization, continuous improvement, reviews, updates and revisions
- Assist implementing new analytical technologies and laboratory techniques
- Lead or contribute to method transfer between internal/external labs
- Support process validation, cleaning validation, stability programs, and comparability studies
- Ensure testing is performed using validated methods and approved procedures
- Maintain compliance with cGMP, GLP, data integrity, and company procedures
- Review data, notebooks, electronic records, and reports for accuracy
- Support calibration, maintenance, qualification, and troubleshooting of instruments
- Identify process improvements and communicate recommendations
- Maintain laboratory readiness for audits
Key requirements- Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Analytical Chemistry, or related field
- 2-5 years of experience in GMP-regulated pharma/biotech environment preferred
- Experience in analytical testing and method validation/transfer preferred
- Working knowledge of ICH, USP, FDA, GMP and data integrity requirements
- Experience with laboratory investigations and regulated environments preferred
- Team collaboration
- Attention to detail
- Technical writing and documentation
- Analytical method development, validation, verification, and transfer
- HPLC/UHPLC
- LC-MS/MS
