Scientist, Quality Control

The Position

This position is in the Quality Control Group, within the Quality Department. An Associate Scientist, Quality Control will support the analytical testing of pharmaceutical raw materials, in-process samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products. The analyst will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The analyst is expected to be proficient in several analytical techniques and can make sound scientific decisions with guidance from management. This position reports to QC Laboratory Management.

Responsibilities

• Knowledgeable of cGMP requirements and ICH guidelines
• Frequently works independently to meet project timelines and deliverables with minimal supervision to no supervision
• Collaborates with Analytical Development on procedural method transfers and may participate in the execution of method validation protocols
• Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and stability samples using established test methods and procedures
• Proficient with various analytical instrumentation theory and practice
• Executes training requirements for assigned SOPs and participates in department specific training modules.
• Independently sets up complex instrumentation for testing according to written test methods and procedural documents to analyze samples
• Demonstrates proficiency with a variety of instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, Endotoxin plate readers, and/or Raman spectroscopy) and will assist in training on instrumentation as
• Performs analyses in a timely and efficient manner to support ongoing prioritized studies
• Works with other departments to ensure project execution and timely/accurate deliverables
• Assists in training of both entry and mid-level analysts.
• Shows initiative and interest in mastering new techniques and tests
• Ability to track/trend data and interpret degrative changes to the product on stability
• Uses stability tracking software as a repository generated results (data entry, review and approval).
• Contributes to and supports scientific technical discussions and brainstorming sessions
• Identifies and troubleshoots analytical method issues with instrumentation, general chemistry, test methodology and sample product
• Communicates laboratory testing issues or challenges to laboratory management
• Maintains a clear, concise, and accurate notebook
• Performs technical data review on data acquired by other QC analysts as applicable
• Drafts technical documents such as COS/atypical investigations, deviations and CAPAs
• Possesses clear written and verbal communication skills
• Embraces cGMP and ICH requirements for all associated work
• Works cooperatively in a team environment
• Demonstrates attention to detail
• Calibration, maintenance, and troubleshooting of analytical equipment under guidance from superior analysts
• Routinely makes sound, scientific decisions with input from Management.
• Demonstrates flexibility and understanding with changing priorities

Requirements:

• M.S. in Chemistry (or related field) with 3+ years relevant laboratory experience
• B.S. in Chemistry (or related field) with 5-7 years of relevant laboratory experience
• Knowledgeable of cGMP and ICH laboratory requirements and operations
• Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices