Scientist I, Quality Control

The Position

This position is within the Quality Control structure, under the Quality Organization. A Scientist I, Quality Control will support the analytical testing of Environmental monitoring samples, pharmaceutical raw materials, in­ process manufacturing samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products. The Senior Scientist I will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The Senior Scientist I is expected to be proficient in several analytical techniques and will be capable of making independent scientific decisions. The position also requires the ability to lead and mentor co-workers. This position reports to QC Laboratory Management.

Responsibilities

• Fully knowledgeable of cGMP requirements and ICH guidelines
• Works independently to meet project timelines and deliverables with minimal supervision to no supervision
• Collaborates routinely 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 completes 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
• Is a subject matter expert in technical aspects of both instrumentation and workflow management and prioritization
• Performs analyses in a timely and efficient manner to support ongoing prioritized studies
• Works closely with other department personnel for efficient project execution and timely/accurate deliverables while building a relationship with respect and communication
• Trains and mentors co-workers (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).
• Owns and leads 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 COAs, investigations, deviations, and CAPAs
• Possesses excellent written and verbal communication skills
• Embraces cGMP and ICH requirements for all associated work
• Works cooperatively in a team environment
• Demonstrates a high attention to detail
• Calibration, maintenance, and troubleshooting of analytical equipment with little to no guidance from management
• Routinely makes sound, scientific decisions independently and serves as a back-up to Laboratory Management
• Demonstrates enduring flexibility and understanding with changing priorities.

Requirements

• M.S. in Chemistry (or related field) with 7+ years relevant laboratory experience
• B.S. in Chemistry (or related field) with 9+ years of relevant laboratory experience
• Fully 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