Laboratory Team Leader, Microbiology and Cleaning Validation

Catalent•Greenville, NC

1d•Onsite

About The Position

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Laboratory Team Leader, Microbiology and Cleaning Validation leads laboratory personnel in daily activities providing coaching and feedback to team members. This role provides laboratory support for internal business units and external client pre-commercial and commercial processes and projects.

Requirements

Associate degree in Biotechnology, Chemistry, or a related scientific field with nine years of professional experience in pharmaceutical analytical chemistry; OR Bachelor’s degree in a science-related field with eight years of professional experience in pharmaceutical analytical chemistry; OR Master’s degree in a science-related field with six years of professional experience in pharmaceutical analytical chemistry; OR PhD in a science-related field with four years of relevant experience in pharmaceutical analytical chemistry.
Experience in a Catalent analytical laboratory in a role independently managing client interactions and projects as well as mentoring and training junior analysts may be substituted for 3 years of professional experience.
Must have experience mentoring and training junior analysts.
Individual may be required to sit, stand, walk regularly and occasionally lift up to 10 pounds.
Some exposure to hazardous chemicals and other active chemical ingredients.

Nice To Haves

Experience in Cleaning Validation and Microbiology preferred.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Responsibilities

Supervise and support development and growth of chemists/scientists in GMP good documentation practices, understanding client project scope, and laboratory technical skills sets by providing on-the-job training, mentoring and guidance.
Resolve conflicts within the group relating to performance and/or workload as well as ensure proper resource allocation within and across teams.
Schedule analytical work and review analytical data packets and analysis reports, as appropriate.
Responsible for development and performance management of direct reports including training, coaching and mentoring.
Lead in the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards.
Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules.
Maintain proficiency in process and data review within respective scientific field of operation in accordance with job responsibility and function, able to troubleshoot instrument, method and technique-related issues.
Initiate and perform investigations for out-of-specification and out of trend results as well as deviations from standard operating procedures; ensure timely and comprehensive investigations in compliance with established internal procedures and root cause analysis techniques.
Develop, and validate, methods for cleaning verification and microbiological methods for excipients, actives and finished products.
Solve problems with methods, instruments, products or processes; interpret and trend data generated, escalate notification procedures as appropriate.
Author and review analytical procedures, validation documents, portions of regulatory submissions for site pre-commercial and commercial projects relating to Analytical.
Correctly operate and maintain laboratory equipment, foresight relating to recommending replacement or upgrade to better meet business needs.
Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable).
Other duties as assigned.