Scientist, Analytical Sciences & Technology

POSITION SUMMARY

The Contractor Scientist within the Analytical Science and Technology team is responsible for supporting analytical method lifecycle activities including method development, qualification, validation, and technical transfer of methods for the testing of raw materials, excipients, biologics and other modalities in-process, drug substance, and drug product samples. The candidate will execute non-GMP testing, non-GMP stability testing, reference standard qualification, and comparability studies to support clinical and / or commercial GMP manufacturing.

Duties / Responsibilities :

• Develop, author, and peer review standard operating procedures, analytical methods, protocols, reports, and other associated scientific technical documents.
• Perform testing of study samples to support upstream and downstream manufacturing process development, characterization, and process improvements.
• Document and evaluate experimental results and perform data verification and trending.
• Provide technical expertise and guidance to support investigations and help troubleshoot analytical operational issues.
• Identify new analytical technologies and opportunities for technical advancements.
• Support the preparation and review of regulatory submissions related to analytical procedures, method development and validation, specifications, reference standards, extended characterization, and product stability / shelf-life.
• Support regulatory inspections, third-party audits, and customer audits through participating in inspection readiness and addressing inspectional findings.
• Perform routine laboratory activities including sample management, instrument maintenance and calibration, inventory and ordering of supplies, general housekeeping, and other related activities.
• Work in a diverse group environment while focusing on inclusivity and safety to produce high quality, compliant results.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc :

Quals

Education / Experience / Licenses / Certifications :

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc :

Physical Demands :

biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics.

Powdered materials and high temperature liquids and solids may also be handled. Use of a respirator may be required.

Work Environment :

Travel :

EEO :