Analytical Development Chemist (Senior)

Job Description

1969 Analytical Development Chemist

Key Responsibilities:

• Participate in Method development and validation to include testing, protocol and report writing
• Review data for compliance to specifications; document and investigate nonconformities
• Perform Routine Commercial Product Release and Stability Testing
• Lead investigations, and/or provide expertise for resolution of laboratory deviations and OOS/OOT results related to reagents and consumables
• Ensure Good Documentation Practices for relevant QC testing procedures, and that documents are current and accurately and clearly describe processes, reagents, and acceptance criteria

Qualifications:

• BS/MS in Chemistry, or closely related scientific discipline
• Proficient in Empower
• 8-10 years relevant quality control experience
• Strong working knowledge of ICH, cGMP, FDA and USP guidance
• Recent experience with method development, qualification/validation and transfer preferred
• Laboratory experience with a variety of analytical techniques including, but not limited to, GC,UV,HPLC, IR
• Proficient in general and non-routine laboratory skills
• Excellent computer, documentation, communication and organizational skills required
• Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment
• Exercises judgment within well-defined and established procedures and practices to determine appropriate action
• Strong interpersonal and verbal/written communication skills required
• Able to respond quickly to shifting priorities and to meet deadlines