Job Description

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Catalent Paragon Gene Therapy is looking to recruit a Quality Control Manager, Microbiology to join our growing team in Harmans, MD.

A Quality Control (QC) Microbiology manager's primary duty is to plan, organize, direct and evaluate the routine activities and project deliverables of the QC Microbiology laboratories to ensure the safety and reliability of products produced in compliance with quality and regulatory requirements.

In concert with Catalent's Patient First philosophy, the QCMicrobiologyManager's role is paramount to ensure the efficacy and quality of the quality Control processes to yield safe, high quality drug products for patients.

The Role

• Oversee the Environmental Monitoring program for ISO/EU classified cleanrooms, including the scheduling of activities for QC Microbiology personnel and assessing data trends
• Responsible for testing of starting materials, in process and release samples for on-time lot disposition utilizing technical expertise in USP/EP/JP compendial tests, such as Sterility, Bacterial Endotoxin, Microbial Enumeration and Biological Indicators
• Lead complex investigations related to sterility assurance and contamination control of the facility, including assigning appropriate CAPA
• Interpreting applicable quality and regulatory requirements
• Develop associated policies and procedures for the Microbiology laboratories operations, interfacing with investigators during both internal and external inspections
• Evaluating audit observations and developing responses and oversight for related action plans, making critical decisions concerning testing operations
• Working collaboratively with manufacturing, technical and product development teams to improve quality, increase efficiency, solve problems
• Generate cost savings, and provide new product support
• Managing operations for the QC Microbiology laboratories and supporting the QC documentation and LIMS activities

The Candidate

• Bachelor's degree in life sciences or equivalent
• 7 - 10 years' experience working in a pharmaceutical or biotechnology organization with at least 5 of those in a GMP Quality Control role required.
• 4 years of direct people leadership required

Catalent's standard leadership competencies that are used to interview and for Performance & Development

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.