Major accountabilities:

Your responsibilities will include, but are not limited to:

• You will be responsible for performing method feasibilities and validate robust analytical methodologies applied to innovative Oligonucleotides/peptide therapeutics. Strong experience in various chromatography techniques is a pre-requisite. Experience in mass spectrometry applied to biological molecules would be an asset.
• Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards.
• Accountable for documentation and submission of raw data in an appropriate data system (for e.g., LIMS test activation and results entry).
• Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities.
• Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
• Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/ glassware management etc.).
• Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory.
• Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).
• Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities.
• Support internal and external audits and ensure no critical findings within the assigned scope.

• Actively contribute to team and organization goals.
• Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines.
• Additional specific roles/tasks: See Up4Growth training assignments for the business roles for the associate as per the team matrix and completion of trainings in transcript of learning system (e.g., Up4Growth).
   

Minimum Requirements
Desirable: PhD in analytical chemistry or equivalent and a minimum 2-3 years’ experience in the pharmaceutical industry in analytical development. Strong expertise in the field of oligonucleotide analytics.

• Profound expertise in liquid chromatography separation techniques such as (RP, IEX and HILIC) is a must.
• Experience in Mass Spectrometry (ranging from mass confirmation to actual quantitative analysis of impurities and sequencing) is an asset.
• Contribution to scientific exchange groups within Novartis
• Proven scientific skills in guiding and mentoring colleagues
• Good knowledge of software and computer tools such as Office package, LIMS, chromatography data-evaluation software (e.g. Chromeleon) etc
• GMP experience is a must
• Knowledge in quality principles driving drug development such as GMP.
• Understanding of general regulatory and quality expectations.
• Good scientific background, communication skills including presentation and scientific/technical writing.
  
   

Work Experience

• Functional Breadth.
• Operations Management and Execution.
• Collaborating across boundaries.