165 days ago on sjobs.brassring.com

Analytical Project Leader

Novartis Pharma Schweiz AG

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Analytical Project Leader

Job ID 215579BR Position Title Analytical Project Leader Division Global Drug Development Business Unit TECHNICAL R & D GDD Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description The position is within the Global Technical R&D (TRD) department of Global Drug Development. Analytical R&D (ARD) plays an essential role in the development of small molecules drug substances and drug products. ARD is responsible for the development of analytical control strategies throughout development until the transfer to commercial production.

We are looking for a highly motivated, experienced Analytical Project Leader. The position entails the following key responsibilities:

• Develop and drive the overall analytical project strategy (API and formulated sterile or topical drug product, mainly small molecules and synthetic peptides)

• Lead and manage all analytical activities within a global project team (e. g. specification setting, method development and validation, stability and release testing)

• Accountable to meet quality, timelines and budget for assigned projects

• Manage interactions with internal and external stakeholders, including outsourced activities

• Proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level

• Provide input to CMC documents to support regulatory submission

• Ensures the distribution of lessons learned and scientific know-how within and across units

• Strong contribution to advance science, technology and innovation within ARD
Minimum requirements • PhD in analytical chemistry or equivalent

• Minimum 3-5 years’ experience in the pharmaceutical industry, preferred analytical development or quality control, preferable for sterile or topical products

• Proven leadership experience in managing projects ideally in a global matrix environment

• Strong quality focus, experience in a GMP environment

• Profound scientific knowledge in analytical development

• Fluent in English (oral and in writing), German desired

• Ability to perform in a highly dynamic environment