Scientist I

Job Summary

The Scientist I is responsible for an intermediate level of expertise in analytical chemistry, chromatographic methods of analysis and instrumentation, including troubleshooting. Independently executes protocols, verifications, method transfers in support of senior level personnel. Directs and provides guidance to associate scientists.

Responsibilities

• Will articulate work related issues clearly and effectively to management and peers.

• Performs accurate routine testing utilizing instrumental methods of analysis (HPLC, GC, FTIR, UV, ICP-MS) with emphasis on chromatography to meet departmental objectives.

• Updates and routes SOPs, MOAs, Specifications through Documentum as delegated by supervisor for USP compliance.

• Provides technical support for method validation, verification, transfers, evaluations.

• Performs troubleshooting of instrumentation by applying problem solving skills and sourcing out literature or vendors, if necessary.

• Provides guidance to Associate Scientist personnel when necessary.

• Assists in the formal training of lab personnel on topics such as GMP, safety, antineoplastic, and new employee training.

• Maintains accurate records of all work performed with respect to a given project. Documents testing in compliance with Good Documentation Practices.

• Manages work and time based on departmental priorities using own judgement and objective reasoning.

• Performs peer review of data to ensure compliance and accuracy.

Requirements:

• B.S. degree in Chemistry or Biology, or equivalent physical science.

• Minimum 1 year of related experience in pharmaceutical industry and a familiarity with cGMP and FDA regulations.

• Must have hands-on experience and knowledge of chromatographic methods and related chromatography data systems (i.e. Empower).

• Must be proficient in Microsoft Office (Word, Excel).

• Some method development experience and extensive troubleshooting knowledge is highly desirable. Must be flexible with continually changing projects and priorities.

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 match, 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.