Manager, QC Microbiology
Catalent Pharma is hiring for an experienced QC Microbiology Manager at our Madison, WI site. The Quality Control (QC) team is responsible for testing products, raw materials and the manufacturing environment to ensure the Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility. This position works to assure that operations at Catalent meet client requirements and cGMP regulations via Quality Control staff. The QC Micro Manager will ensure responsiveness to clients and overall client satisfaction. Responsible for coordinating and implementing activities to attain strategic objectives within a department and looks to his or her direct supervisor or other peers within the industry for guidance. In addition, the manager is able to establish goals and objectives, supervise work practices for direct reports, interprets and executes policies and procedures that typically affect organizational units. This position will interact with other departments or divisions within Catalent. At the senior level, this position requires extensive independent judgment.
The Role (daily responsibilities)
- Manages the Quality Control Microbiology department daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems.
- Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state and local regulations. Consults with Human Resources Department as appropriate.
- Ensures Quality Control systems are compliant with corporate and site procedures, as well as industry standards.
- Interacts with customers during meetings and visits; provides responses to customer’s questions.
- Supports development of novel QC microbiological methods and expands throughput of laboratory looking at new technology for integration. Works in conjunction with other departments to develop, qualify, and transfer QC microbiological methods.
- Ensures maintenance of QC equipment – qualification, calibration and maintenance.
- Participates on Validation Team and Project Teams, as applicable.
- Leads the CAPEX process for QC Microbiology; including commissioning and qualification of new equipment, instruments, including major capital projects and computer systems.
- Drafts, reviews, and approves Standard Operating Procedures (SOP), sampling plans, specifications, protocols and reports related to product/processes, equipment, method, validation. This includes deviation investigation and reporting.
- Manages contractors as required.
- Develops and implements statistical tools for Quality Systems monitoring and review.
- Reviews and approves changes to critical processes, facilities, equipment and systems through the change control program to assess impact on validated systems.
- Assists in customer / regulatory audits and responding to audit observations and corrective actions.
- Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
- Collaborates significantly with cross functional groups, including QC Analytical, QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
- Provides technical assistance and training for personnel
- Files and maintains controlled documents.
- Other duties as assigned.
The Candidate (requirements)
- PhD in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum 6 years’ related experience with demonstrated career progression including leadership responsibilities OR
- Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum 8 years’ related experience with demonstrated career progression including leadership responsibilitiesOR
- Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum 10 years’ related experience with demonstrated career progression including leadership responsibilities.
- Potential for career growth within an expanding team
- Defined career path and annual performance review and feedback process
- Medical, Dental, Vision and 401K are all offered from Day One of employment
- 19 days of paid time off annually + 7 paid holidays
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.
Catalent. More products. Better treatments. Reliably supplied. ™
Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.