LEAD SCIENTIST

Job Summary

The Lead Scientist will be responsible for supporting the analytical method transfer activities to manufacture Biosimilar drug products in a state-of-the-art high speed pre-filled syringe facility. The incumbent will be responsible for validating test methods, test method verification, test method transfers, and release and stability testing for biosimilars, ensuring the laboratory successfully operates in compliance with cGMP expectations and other laboratory regulations governing the manufacture of biotherapeutics.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Support qualification, validation, and transfer of analytical methods in support of QC release and process support for Biosimilar drug products.
• Routine and non-routine analysis including stability assessments and data trending.
• Lead projects and studies, execute analytical test methods, organize the data and author related technical documents.
• Develops new Standard Operating Procedures for laboratory test procedures.  Maintains SOPs to assure constant compliance with corporate and regulatory requirements.
• Reviews work performed by department staff for accuracy, completeness, and conformance to specifications and protocol acceptance criteria.
• Monitors and tracks laboratory test results.
• Schedules, initiates, and/or coordinates QC testing of biosimilar drug products for release in US and in other regulated markets (EU)
• Trains QC department personnel in new/revised Standard Operating Procedures and new/revised Method of Analysis.
• Investigates nonconforming test results for product dispositions, evaluates results to provide conclusions and appropriate action.
• Develops protocols for laboratory methods and production process validations.  Participates in performing validation work.  Performs studies and validations required to support Product Development.
• Serve as owner for multiple analytical instrumentation that supports biosimilar drug products, working as subject matter expert (SME), training as needed and maintaining the instrumentation. 
• Maintains knowledge of cGMP’s and GLP’s.
• Performs other duties as assigned by management.

REQUIREMENTS

• B.S. in Biochemistry or related scientific discipline, advanced degree preferred.
• Minimum 5 years of biotech/pharmaceutical industry experience.
• Experience in protein or large molecule testing using the technique of Size Exclusion-HPLC, Capillary Electrophoresis, and SDS-PAGE.
• Must have excellent written and oral communication skills, the ability to multitask, and must possess inherent leadership skills.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.