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Scientist - Biologics

Posted on Apr 5, 2021 by Catalent Pharma Solutions

Kansas City, MO 64190
Research
Immediate Start
Annual Salary
Full-Time


The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Solutions business. Our talented team has over 25 years of experience providing analytical services for projects spanning multiple large molecule modalities/compounds. The Biologics II team concentrates and has expertise on the following analytical methodologies/technologies:


HPLC/UPLC


Karl Fischer


Compendia assays, (ie appearance. pH, etc.)


UV-Vis, Solo-VPE, Nano Drop


Position Summary


The main activities for the Scientist, Biologics II will be to provide and report data, as required by project contracts within the Biologics Department. The data may be used for submission in Regulatory packages, release and stability testing of clinical and animal trial dose forms and in support of development projects.


The Role


In support of large molecule therapeutics, develop and execute laboratory work, plans/schedules independently using customer milestones and Division/site performance standards and metrics. Sample types include in-process, release or stability for CMC support. Techniques may include any or all of the following:


HPLC/UPLC techniques/methods (eg SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis, etc.)


Karl Fischer


Compendia assays, (ie appearance. pH, etc.)


UV-Vis, Solo-VPE, Nano Drop


Aggregation techniques such as MFI, AUC, SEC-MALS


Perform method validation or transfer activities, as needed. Under direction, perform method development activities


Perform various types of testing under cGMP, as appropriate.


Author technical documents, such as protocols, test methods, reports, certificates of analysis, and operating procedures. Review technical documents for accuracy, thoroughness and regulatory compliance


The Candidate


Education:


Degree in life sciences such as analytical chemistry, biochemistry, chemical engineering, biology or closely related physical science. Bachelors Degree: 7-9 years of relevant experience preferred or based on performance at Catalent. Masters Degree: 2-4 years of relevant experience preferred or based on performance at Catalent. Doctorate Degree: 0-2 years of relevant experience preferred or based on performance at Catalent.


Knowledge/Skills Requirements:


Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs


Ability to learn and retain technical information


Develop and execute complex procedures or methods with high quality


Excellent written and verbal communications skills with internal and external customers


Well organized with ability to multitask


May publish or present externally.


Catalent's standard leadership competencies


Leads with Integrity and Respect


Delivers Results


Demonstrates Business Acumen


Fosters Collaboration and Teamwork


Champions Change


Engages and Inspires


Coaches and Develops




Reference: 1152695746

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