The Position
This position falls within the Quality Control structure, under the Quality Assurance Organization. A Quality Control Team Leader will manage chemists and help to support the analytical testing of 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 while carrying out a supervisory function.
The Quality Control Team Leader will also manage and support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The Team Leader will also be 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 chemists who are new to the industry. This position reports to QC Laboratory Senior Management.
Responsibilities
Management • Provide leadership and guidance to a team of QC chemists, ensuring their professional growth and development. • Set clear performance expectations, provide regular feedback, and conduct performance evaluations. • Foster a collaborative and inclusive work environment that encourages teamwork, creativity, and innovation. • Attend and contribute to regular leadership meetings between cross-functional departments.
Scientific/Laboratory • Fully 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 • Proficient with various analytical instrumentation theory and practice • Executes training requirements for assigned SOPs and participates in department specific training • 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 analyst training on instrumentation as needed • Is a subject matter expert in technical aspects of both instrumentation and workflow management and prioritization • Works closely with QA, Analytical Development and/or Manufacturing personnel for efficient project execution and timely/accurate deliverables • Trains and mentors both entry chemists as well as mid-level chemists • Ability to track/trend data and interpret degrative changes to the product on stability • Leads and assists in 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 senior laboratory management • Maintains a clear, concise, and accurate notebook • Drafts technical documents such as OOS/atypical investigations, deviations and CAPAs • Possesses clear written and verbal communication skills • Embraces cGMP and ICH requirements for all associated work • Calibration, maintenance, and troubleshooting of analytical equipment in collaboration with metrology • Routinely makes sound, scientific decisions and serves as a back-up to Senior Laboratory Management
Requirements
Masters in Chemistry (or related field) with 5+ years relevant laboratory experience Bachelors in Chemistry (or related field) with 7+ 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