cGMP Biomanufacturing Upstream Specialist, Cell Banking

Catalent

Madison,WI  

2019-12-12 2020-01-11
pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



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











Position Summary



Catalent is hiring a cGMP Biomanufacturing Upstream Specialist, Cell Banking in Madison, WI.







In concert with Catalent’s Patient First philosophy, the Upstream Cell Banking Specialist is responsible for timely production of high viability, high cell density, and stable Master Cell Bank products. These products include Master Cell Banks, Working Cell Banks, and End of Production Cell Banks. Cell Banks will be produced from a variety of starting materials and varying procedures used to create the banks. The Cell Banking Coordinator will work to ensure compliance with FDA and ICH guidelines. They are also responsible for the maintenance of Cell Banking inventory used for future GMP production.







The Role





+ Creates, executes, and documents all procedures used in the manufacture of Master Cell Banks (MCBs), End of Production Cell Banks, and Working Cell Banks.



+ Writes and reviews GMP Standard Operating Procedures (SOPs) related to Cell Banking and Manufacturing as applicable.



+ Monitors GMP Cell Banking inventory and log books.



+ Ensure compliance of environmental monitoring in the Master Cell Banking area.



+ Ensure the timely production of high viability, high cell density, and stable Master Cell Bank products.



+ Monitor equipment and staffing needs to ensure proper levels for continued production.



+ Train Manufacturing personnel on Cell Banking procedures.



+ Writes MCB final reports and other client facing documents.



+ Works with the Cell Line Development group to transfer procedures and practices in order to produce effective Master Cell Banks.









The Candidate





+ Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 7 years’ related experience required.



+ Typical minimum of 7 years of cell culture experience.







+ Must have GMP or GLP experience.



+ Must have mammalian cell culture experience. Preferred CHO cell line experience.



+ Knowledge of cryopreservation of mammalian cell lines required.



+ Advanced project management skills are routinely practiced for multiple concurrent projects of moderate to high complexity.



+ Ability to complete investigation, deviation, and change control forms independently.



+ Ability to interpret, provide and manage a variety of instructions furnished in written, oral, diagram, or schedule form across multiple work groups.









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









Why Catalent?





+ Diverse, inclusive culture



+ 152 hours of Paid Time Off per year



+ Medical, dental, and vision insurance, as well as company matching 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.







personal initiative. dynamic pace. meaningful work.Visit www.catalent.com/careers to explore career opportunities.











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, 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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





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 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.











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.
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