Manager, QC Microbiology

3 days left

Employer
Catalent Pharma Solutions
Location
Harmans, Maryland, US
Salary
Competitive
Posted
Jul 11, 2021
Closes
Aug 06, 2021
Ref
2065960957
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Job Description
Position Overview:
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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
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 Cell and 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 QC Microbiology Manager'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
- 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
Position Benefits
- Join a high growth and fast paced organization with a people focused culture
- Global exposure, defined career path and annual performance review and feedback process
- Competitive Medical, Dental, Vision and 401K
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 www.catalent.com/careers to explore career opportunities.
C atalent 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, protected veteran status, sexual orientation or gender identity. 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.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if...
- You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
- You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year - more than any branded drug maker in the world!
- You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
- You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
- You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!
- See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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