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Catalent

Scientist II - Quality Control, Stability

Catalent, Madison, Wisconsin, us, 53774


Scientist II - Quality Control, StabilityCatalent 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.Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.This position requires a variety of skills necessary for biotech company operations. The position will perform routine testing of in-process samples, raw materials, finished goods and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The position will analyze and interpret results in written and oral format. Additionally, this position will support preventive maintenance and basic laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review, and contributions to process improvement initiatives.This is a full-time on-site salaried position, Monday through Friday 8:00am to 5:00pmThe Role:Independently executes and properly documents cGMP Quality Control testingIndependently operates basic and moderately complex cGMP Quality Control equipmentAssists in authoring technical documents such as SOPs and reportsCoordinates with Supervisor to prioritize and schedule activities to meet deadlinesSupports continuous process improvement initiatives; Supports training of specific analytical techniquesPerforms self-review of analytical data for accuracy and consistency with SOP; Enters data into Laboratory Information Management System (LIMS) or laboratory reportsInitiates and assists with records in TrackWiseAccurately completes route and preventative maintenance on basic to moderately complex equipmentOther duties as assignedThe Candidate:Must have Master’s Degree in Biology, Biotechnology, Chemistry or related life sciences field within a minimum of 1 year of industry experience

ORBachelor’s Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 4 years of industry experience

ORAssociate’s Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 8 years of industry experience

ORHigh School Diploma or equivalent is required with a minimum of 9 years of industry experienceRequires frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 lbs.Preferred Experience:Strong understanding of analytical chemistry and simple and moderately complex lab equipmentExperience maintaining and troubleshooting Quality Control EquipmentFamiliarity with clean room procedure, aseptic technique, and general lab equipment experienceCGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge.Why you should join Catalent:Defined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives152 hours of paid time off annually + 8 paid holidaysCompetitive salary with yearly bonus potentialCommunity engagement and green initiativesGenerous 401K match and Paid Time Off accrualMedical, dental and vision benefits effective day one of employmentTuition ReimbursementCatalent 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.

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