For one of our clients - a global medical devices company - we are looking for an Analytical Leader who will be accountable for the design and execution of the analytical strategy for the Nutrition Department, for steering the global analytical transfer plan and leading a cross functional team of analytical experts.
As leader you need to keep the helicopter view of each project (cfr. infra) in a complex environment.
- Accountable for design and execution of the analytical strategy plan for Exploratory, New Product Development or Sustaining projects, covering drug substance, excipients, in process controls and drug product (release and stability)
- Leads the analytical transfer plan globally to manufacturing plants, CRO and other RD centres, local-second release sites….
- Leads product and/or method comparability/equivalence studies to enable the continuation of the analytical method lifecycle
- Leads the budget and resource planning for the execution of the analytical strategy plan. Identifies all analytical resources needs, capabilities and capacity required in projects. Assures budget estimates and control. Works with partners, internal and external to assure appropriate resource load to the projects
- Acts as the go-to person for technical leaders with their analytical requests
- Leads a cross functional team of analytical experts with internal / external labs / suppliers. Assures the right analytical expertise and skills are provided to the core team.
- Act as Analytical spoke person during MOH audits. Responsible for timely and adequate Analytical Q&A with authorities. Present and negotiate Baxter analytical strategy plan at MOH scientific meetings
- Leads analytical innovation for/at the core team. Explores and assures that novel analytical techniques/SME’s are available to support the business strategy
- Assures that the Analytical test designs are fit for purpose and in sync with the business needs
- Minimum master’s in science: Analytical, Organic Chemistry, Biochemistry, Bio-engineering, Pharma Science…
- Very good level of written and spoken English
- Minimum 8 years of experience in Analytical Development or in a similar position in Pharma
- Excellent knowledge of chemistry, biochemistry and analytical techniques as well as method validation/verification/transfer design
- Strong leadership skills
- Strategic thinking and problem-solving expertise. Ability to apply these skills in multiple areas with speed and agility
- Good cross-cultural interpersonal skills, with ability to drive coordination across cross-functional teams, internally and externally.
- Excellent Project Management skills