Laboratory Team Leader, Microbiology and Cleaning Validation

Laboratory Team Leader, Microbiology and Cleaning Validation

Position Summary: 

• Work Schedule: Monday-Friday, Days.
• 100% based on-site in Greenville, NC

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.

The Role:

• 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.

The Candidate:

• Requires an 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.
• Experience in Cleaning Validation and Microbiology preferred.
• Must have experience mentoring and training junior analysts.
• 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.
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 10pounds.
• Some exposure to hazardous chemicals and other active chemical ingredients.

Why you should Join Catalent:

• Day one benefits! Medical, dental, vision and 401K benefits effective on your first day. 
• 152 hours of PTO + 8 Paid Holidays.
• Dynamic, fast-paced work environment.
• Opportunity to work on Continuous Improvement Processes.

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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