Supervisor, QC Microbiology

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

This Supervisor, Quality Control Microbiology is responsible for effectively managing, developing, coaching, counseling, and motivating the QC staff. The Supervisor is responsible for ensuring the timely and accurate completion of required environmental monitoring of cleanrooms and sampling and testing clean utilities, raw materials, in-process, and finished product samples. They ensure compliance with GMP and company specifications as well as relevant pharmacopeia compendia. The Supervisor identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory. The Supervisor keeps laboratory management informed of all departmental activities and product-related events.

This position is 2nd shift Monday-Friday 2pm-10pm and will reside at the Baltimore/BioPark site.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role
• Supervises daily activities of QC Microbiology analysts and ensures that job activity deadlines are met on a timely basis; Assists with hiring and oversees the training and mentoring of QC Microbiology personnel. Ensures that steps are taken to maintain positive personnel morale and development.
• Ensures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities, and effectiveness of production processes.
• Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Formally investigates causes and determines corrective actions needed and evaluates the impact on the product; Identifies adverse microbial quality trends and prepares and analyzes Environmental Monitoring trend reports.
• Revises and generates new Standard Operating Procedures for Environmental Monitoring and Microbiology test procedures as needed to comply with cGMPs and company policies.
• Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports
• Represents the QC Microbiology department in cross functional teams and internal/external meetings.
• Reviews work performed by department staff for accuracy, completeness and conformance to GDP and product specifications; Mentors and develops new department personnel including training in Standard Operating Procedures and On The Job Training (OJT)
• Assumes other QC Microbiology-related duties and responsibilities as assigned.

The Candidate
• B.S. in a Life Sciences discipline and 5-10 years of relevant and progressive experience working in Quality Control, with 1-2 years of leadership experience.
• Familiarity with Good Manufacturing Practices (cGMP's) and pharmacopeial along with hands-on experience in cGMP cleanrooms.
• Experience with viable and non-viable environmental monitoring collection techniques, instruments, and qualifications/validations, including in an aseptic manufacturing environment; Document writing, data interpretation, presentation, statistical analysis, and trending preferred.
• Experience with Bioburden, Endotoxin, and Microbial identification assays
• Has the knowledge and ability to apply advanced scientific and regulatory principles to solve operational and routine quality tasks and troubleshoot problems.
• Self-starter with the ability to produce results in a fast-paced environment to meet deadlines under minimal supervision.
• Ability to remain in manufacturing cleanrooms while aseptically gowned or in lab environments for extended periods of time.

Why you should join Catalent:
• Defined career path and annual performance review and feedback process
• 19 days of PTO + 8 paid holidays
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

California Job Seekers can find our California Job Applicant Notice HERE.
Summary

• Location: Baltimore, MD
• Type: Full time