Catalent Pharma Solutions Manager, Quality Control in Gaithersburg, Maryland
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)
Catalent Gene Therapy is looking to hire a Quality Control Manager to support our growing team in Gaithersburg, MD
The Quality Control (QC) Manager is responsible for supervising routine QC testing on cleaning, in-process and release samples. The QC Manager will also assist analytical method transfers and method qualifications between the Analytical Development group and Quality Control.
Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with 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.
Oversight and maintenance of Catalent’s quality control analytical testing program (including assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC / UPLC and Capillary Electrophoresis)
Oversight of assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, ddPCR, HPLC/UPLC and Capillary Electrophoresis. Performance of these assays by the individual may be required.
Generate internal and external documents such as assay protocols, summary reports, and SOPs
Provide instrumentation care, maintenance, troubleshooting, and data interpretation
Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured
Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
Ensures compliance with cGMP and safety requirements within the QC analytical laboratory
Participates and carries out continuous quality improvements in the QC laboratory
Participates in project specific, system, client, and vendor audits
Maintains QC analytical laboratories and facilities in an audit ready status at all times.
Conducts training on applicable SOPs, regulatory requirements and quality initiatives
BS with 6 years (will consider reduced levels of experience with increased levels of education)
4+ years of people leader experience preferred
Experience with protein chemistry, cell and molecular biology assays (HPLC, ELiSA, qPCR, ddPCR)
Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices.
Experience leading and writing laboratory investigations, deviations, CAPAs and change controls ensuring on-time closure of these quality records.
Experience in writing SOPs and test methods, method qualification/validation documentation, stability protocols and reports as well as annual product performance reports preferred
We will identify candidates based on the following:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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) .
Catalent Pharma Solutions
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