QC Senior Scientist- Raw Materials
Lonza•Portsmouth, NH
•Onsite
About The Position
As a QC Scientist I, Raw Materials, you will support the testing and release of raw materials used in the manufacture of life-changing therapies. Working within the Quality Control team, you will perform laboratory testing, support method transfers and validations, investigate quality events, and collaborate with cross-functional teams to ensure materials meet quality and regulatory requirements. This role is an excellent opportunity for a scientist who enjoys solving technical challenges, driving continuous improvement, and contributing to a fast-paced GMP environment.
Requirements
- Bachelor's degree in Chemistry, Biochemistry, or related scientific discipline required
- Knowledge of analytical testing, method transfers, and method validation principles
- Strong technical writing, documentation, and data review skills
- Ability to analyze data, troubleshoot issues, and identify solutions
- Strong organizational and time management skills with the ability to manage multiple priorities
- Excellent written and verbal communication skills
- Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint
Nice To Haves
- Advanced degree (MS or PhD) preferred
- Experience in a GMP-regulated laboratory, pharmaceutical, biotechnology, or related environment preferred
- Experience with pharmaceutical compendia is a plus
- Experience with quality systems such as LIMS, TrackWise, DMS, or electronic laboratory notebooks preferred
Responsibilities
- Perform laboratory testing to support method transfers, validations, investigations, and routine quality control activities
- Author and review technical documents, protocols, reports, and test methods
- Support the successful transfer and implementation of analytical methods within the laboratory
- Review analytical data and ensure testing is completed in compliance with GMP and data integrity requirements
- Lead or support validation, transfer, and investigation activities through completion
- Set up and verify laboratory equipment, electronic templates, and testing systems
- Participate in cross-functional project teams and collaborate with Quality, MSAT, and Logistics partners
- Investigate laboratory events, identify root causes, and support corrective actions
- Train and mentor colleagues on laboratory methods, procedures, and best practices
- Drive continuous improvement initiatives to enhance laboratory efficiency and compliance
- Act as an SME on Raw Material compliance, supporting audits, technical transfers, and both internal and external stakeholders
Benefits
- Medical, dental, and vision insurance
- Compensation programs that recognize performance
- Opportunities to grow and develop your career
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What This Job Offers
Job Type
Full-time
Career Level
Senior
