Scientist I - Quality Control, Data Review

Scientist I - Quality Control, Data Review

Position Summary:

• Work Schedule: M-F 8am-5pm
• 100% on-site

Catalent Biologics is afast growingbusiness within Catalent Pharma Solutions focused on providing innovative technologies and solutions to helpmore and betterbiologic treatments get to patients. The business includes our proprietaryGPExcell line engineering platform, our newstate-of-the-artbiomanufacturing facility in Madison, WI, andour marketleading biologics analytical services in Kansas City, MOand Research Triangle Park, NC, as well asSMARTagAntibody 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.

Catalent Pharma Solutions in Madison, WI is hiring a Scientist I - Quality Control, Data Review. Thispositionrequires a variety of skills necessary for biotech company operations. The basic purpose of the QC Reviewer is toassurethe quality of laboratory data and reports. This isaccomplishedby reviewing chromatographic data and related notebooks as specified by Standard Operating Procedures. Theobjectiveof the QC review process is to evaluate chromatographic data toassurecompliance with analytical methods, FDA's Good LaboratoryPracticesand/or Good ManufacturingPracticesand client criteria.

The Role:

• Accurately review analytical and/or microbiological testing following SOPs.
• Reviews and verifies analytical and/or microbiological data and reports, ensuring accuracy and consistency.
• Provide clear feedback for corrections needed.
• Activelyparticipatesin team meetings.
• Other duties as assigned.
• All other duties as assigned.
  

The Candidate:

• M.S./M.A. in Biotechnology, or related field, with no prior experience; or

• B.S./B.A. in Biotechnology, or related field, with minimum of 3 years’ experience in related laboratory work; or

• Associates Degree/Certificate/Diploma in laboratory science with minimum of 4 years’ experience in related laboratory work
• Knowledge of chromatography, Standard Operating Procedures, and FDA regulations.
• > 3 years of QC experience; lab experience preferred
• Preferred knowledge includes but is not limited to HPLC, SDS-PAGE, Western Blot, HPLC,cIEFand ELISA experience, and/or Microbiology testing.
• Familiar with cGMP documentation practices.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement- Let us help you finish your degree or start a new degree!

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 Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

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