A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Analytical Scientist (Analytical Development)
Job Description:
The analytical development scientist or specialist within the Pharmaceutical Science group has the responsibility of developing chromatography, bioanalytical and characterization methods to support clinical and commercial development for all of Novartis new vaccine candidates. This role functions in both development and GMP setting and is focused on analytical development activities to support both bulk and drug product. The analytical testing includes in-process, release and stability studies. The specialist will also identify and develop new analytical technologies, testing methods and equipment.
Major Duties:
• Support chromatography and bioanalyical method development for viruses, recombinant proteins, virus-like particles, nucleic acid, etc…in support of bulk process and formulation development.
• Contribute to the development and transfer of analytical release and characterization assays as well as subsequent transfer and implementation of tests within QC labs for both Drug Substance (DS) and Drug Product (DP) development to support Phase I/II/III and/or Commercial Manufacturing.
• Collaborates with bioprocess, formulation and MS&T scientists to lead the development of analytical testing methods to support clinical development, process validation and commercial manufacturing of both DS and DP for new vaccines for internal or external manufacturing partners.
• Collaborates with other TD functions within CM&C team to meet aggressive project timelines.
• Contribute to regulatory filings and interactions with health authorities to ensure successful registration of DS and DP.
• Must be able to work on multiple projects internally, at other sites and at external manufacturers requiring initiative and judgment.
• Present results internally and externally at industry and scientific conferences. Publish in top tier journals.
Candidate Profile:
• BS / MS / PhD in analytical chemistry, biochemistry, biophysics, pharmaceutical chemistry or related field. PhD preferred.
• BS/MS with 5 years of related experience, PhD with 0 years of related experience
• Experience must be in analytical development within
vaccine and/or biotechnology industry
• Good understanding of cGMP, pharmacopea testing and regulatory requirements for filing and registration of vaccine and/or biologics preferred
• Must be fluent in english speaking / writing
• Must have hands-on and in-depth understanding of different protein characterization techniques and associated instrumentation (SEC, IEC, HPLC, Capillary Electrophoresis and Mass Spectrometry or hands-on experience with different protein biochemical assay such as BCA, ELISA, Western Blot
• Additional hands-on experience and understanding of biophysical techniques is desirable
• The qualified candidate must be able to effectively partner with a diverse team members from various functions, multiple countries and members at various levels in organization.
• Must be a self-starter, be able to work with minimal supervision in a matrix environment and effectively manage multiple projects.
Additional Information:
Location: Holly Springs, NC
Education: BS, MS, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 96396BR
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