QC Chemistry Group Lead

Summary

The QC Chemistry Group Lead ensures the fundamental integrity of the laboratory infrastructure. This position oversees routine and non-routine analysis of proteins, peptides, small molecules, large molecules, and ADCs, and supports the development of procedures & initiatives to reach departmental goals.

Essential Job Functions

• Leads and/or collaborates on method establishment (e.g. method verification, qualification, transfers and validations) for compendial assays and other chemistry methods.
• Performs routine analysis and testing for compendial assays such as pH, osmolality, extractable volume, density, particulate matter, HVLD and appearance, as well as ELISA, CE-SDS, SDS-PAGE, viscosity and moisture content.
• Provides scientific direction and technical problem solving to team members and internal stakeholders.
• Interacts with clients and follows up on client inquiries.
• Reviews data, technical reports, deviations, OOS investigations and test results and provides conclusions and proposals for future directions.
• Technical writing of investigations for deviations and out of specification reports.
• Ensures the maintenance of laboratory instrumentation.
• Regular and reliable attendance on a full time basis.

Education and Experience

• Associate’s Degree or equivalent required. Bachelor’s degree in a Life Sciences discipline strongly preferred.
• Minimum of 4 years of relevant experience in quality control.
• Minimum of 1 year of functional or day to day leadership experience.
• Working knowledge and experience with GMP regulations, good documentation practices, troubleshooting, and data entry.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Demonstrated ability to follow detailed directions in a laboratory environment.
• Must be proficient with Microsoft Office applications.
• Experience with electronic Quality Systems preferred.

Leadership Responsibilities

• Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
• Engages employees by creating a climate in which they want to do their best.
• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
• Maintains employee work schedules.
• Provides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.