Analytical Scientist

SciPro are working with a pharmaceutical manufacturing client to identify an Analytical Scientist to assist with a range of ongoing analytical technology transfer projects. This is a 12-month freelance contract based in Norway.

Key Responsibilities

• Coordinate and deliver analytical method transfer activities, including planning, execution and documentation of results.
• Develop and refine analytical methods, resolving technical issues and implementing improvements where needed.
• Produce and maintain protocols and reports covering analytical method validation and transfer.
• Carry out analytical method validation and verification testing in line with project requirements.
• Provide analytical support across product development, technology transfer and commercial manufacturing activities.
• Analyse Process Validation (PV) batches and compile the associated technical reports.
• Oversee stability testing programmes, from study planning and sample analysis through to data assessment, trending and final reporting.
• Support the qualification and introduction of analytical methods for APIs, excipients, intermediates and finished drug products.
• Review analytical data to ensure accuracy, traceability and adherence to GMP and data integrity standards.
• Assess analytical results, investigate deviations and OOS/OOT findings, and help determine appropriate corrective and preventative measures.
• Contribute to regulatory documentation and responses to customer queries.
• Work cross-functionally with Project Management, Production, QA, QC teams and external clients to support project delivery.
• Take responsibility for analytical workstreams within assigned projects, ensuring deliverables meet agreed deadlines and quality standards.

Required Qualifications

• At least 5 years of experience working in pharmaceutical analytical laboratories.
• Proven practical experience in analytical method development, validation, verification and technology transfer.
• Hands-on expertise using HPLC, UPLC and GC analytical techniques.
• Good working knowledge of GMP standards and data integrity requirements.
• Experience analysing APIs, excipients and finished products, with exposure to process validation activities.
• Demonstrable experience preparing analytical protocols, technical reports and supporting documentation.
• Confidence in independently reviewing scientific data, interpreting results and making evidence-based conclusions.

Preferred Qualifications

• Background in a CDMO/CMO environment or within pharmaceutical manufacturing or product development.
• Involvement in regulatory submission activities and preparation for customer audits.
• Experience managing stability studies and applying statistical techniques to analytical data.
• Experience investigating deviations, OOS/OOT results and resolving analytical method issues.