PKS Integration Operations Manager

Key Responsibilities

• Guide and support the PKS subteam on the integration process
  • Review of relevant documents ( BioA, ADME etc… )
  • Bioanalytical reports (MVR, TKR, BDR, IG, analytical plans).

• Prepare the "FDA" tabulated summaries and highlight missing validation steps and gaps
• Work on the inventories of studies, study samples, drug, reference substances and critical reagents, work closely with the BA SME to provide recommendations on what needs to be transferred to Novartis.
  Get a clear understanding about the nature, volume and current location of the raw data.
• Contribute to data transfer to Novartis repositories
• Contribute to Source Data Verification
• Liaise with Biomedical Research integration office representative
• Liaise with Procurement, IT, Legal and other LF related to M&A

Essential Requirements

• PhD with at least 3 years of industry experience, or a master’s degree with at least 6 years of industry experience, in biochemistry, chemistry, pharmaceutical sciences, or a related field. Project management experience or skills are preferred; an MBA is an asset.
• Prior experience as a bioanalytical scientist in a GCP-regulated environment is preferred.
• Strong understanding of GxP guidelines, FDA regulations, and ICH guidance related to sample management, laboratory documentation, and lab operations.
• Familiarity with general PK sciences, including ADME, PK, and bioanalysis, is a plus.
• Strong communication and organizational skills, with the ability to work independently and collaboratively across multiple projects while meeting timelines.
• Willingness to take on additional responsibilities as needed, with the flexibility to adapt to changing priorities and strategies.