Scientist I

Job Description

Job Summary:

• Responsible for an intermediate level of expertise in analytical chemistry, chf0matogfaphic 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.

Principal Activities Performed By The Incumbent:

• Be able to 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 Producing 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, Compliance with Good Documentation Practices.
• Manages with and time based on departmental priorities using own judgement and objective reasoning.
• Preforms peer review of data to ensure compliance and accuracy.

Requirements:

• Possess a B.S. degree in Chemistry or Biology, or equivalent physical science.
• HPLC Experience, Wet Chemistry, Technical Writing.
• Industry-specific experience- Pharma, Med device.
• Typically, 1-4 tears 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).
• KF Water.
• Must be proficient in Microsoft Office (Word, Excel).
• Some method development experience and extensive troubleshooting knowledge are highly desirable.
• Must be flexible with continually changing project and priorities.