Laboratory Team Leader

Catalent•Greenville, NC

7h•Onsite

About The Position

The Laboratory Team Leader leads laboratory personnel in daily activities, providing coaching and feedback, and supports internal business units and external clients with pre-commercial and commercial processes and projects. The role is based at Catalent’s Greenville, North Carolina site and is 100% onsite, Monday through Friday, 8:00 a.m. to 5:00 p.m. The leader develops and supports chemists and scientists through training, mentoring, and guidance in GMP documentation practices, client project scope, and laboratory technical skills. The role coordinates workload and resources, schedules analytical work, reviews data packets and analysis reports, and manages direct-report performance and development. It also promotes quality and safety, ensures work follows approved procedures and applicable cGMP requirements, troubleshoots analytical instruments, methods, and techniques, and leads investigations into out-of-specification or out-of-trend results and procedural deviations. The position identifies opportunities to improve efficiency, customer service, and teamwork; monitors key performance indicators; and manages projects while representing Analytical in interactions with internal and external clients and, as required, CMOs. Other duties may be assigned. The role involves sitting for most of the workday, lifting up to 10 pounds unassisted, and some exposure to hazardous and other active chemical ingredients.

Requirements

Associate degree in Biotechnology, Chemistry, or an equivalent science field and 9 years of professional experience in pharmaceutical analytical chemistry; or
Bachelor’s degree in a science-related field and 8 years of professional experience in pharmaceutical analytical chemistry; or
Master’s degree in a science-related field and 6 years of professional experience in pharmaceutical analytical chemistry; or
PhD in a science-related field and 4 years of relevant experience in pharmaceutical analytical chemistry.
Experience in a Catalent analytical laboratory independently managing client interactions and projects, and mentoring and training junior analysts, may substitute for 3 years of professional experience.
Ability to lift up to 10 pounds unassisted.

Responsibilities

Lead and support laboratory personnel in daily activities, providing coaching and feedback.
Train, mentor, and guide chemists and scientists in GMP good documentation practices, client project scope, and laboratory technical skills.
Resolve group conflicts related to performance or workload and ensure appropriate resource allocation within and across teams.
Schedule analytical work and review analytical data packets and analysis reports, as appropriate.
Develop and manage the performance of direct reports, including training, coaching, and mentoring.
Promote a climate of quality and safety and identify and monitor quality and safety standards.
Ensure work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs, and within agreed schedules.
Maintain proficiency in process and data review in the relevant scientific field and troubleshoot instrument-, method-, and technique-related issues.
Initiate and conduct investigations into out-of-specification and out-of-trend results and deviations from standard operating procedures, ensuring timely, comprehensive investigations and root-cause analysis.
Identify and recommend improvements to efficiency, customer service, and teamwork, and monitor key performance indicators.
Manage projects and represent Analytical with internal and external commercial and pre-commercial clients and, as required, CMOs.
Perform other duties as assigned.