J&J Family of Companies Scientist Global Life Cycle Management - Technical Owner - temporary position in Beerse, Belgium
PDMS - Scientist – Global Life Cycle Management – Technical Owner
Product Lifecycle Management and Specifications is a department of Pharmaceutical Development and Manufacturing Sciences - Analytical Development (PDMS-AD), within the Janssen R&D organization. The department is responsible for:
The management of the specifications for the Janssen commercial products (from starting materials to active pharmaceutical ingredients – API’s – and drug products for both small and large molecules)
The coordination of the analytical activities in PDMS-AD related to commercial products and central point of contact with the Janssen Supply Chain (JSC)
The Scientist will, as an Analytical Development – Technical Owner, be responsible for
Timely and successful completion of lifecycle management programs for a portfolio comprised of pharmaceutical products, including:
Science/risk based management of specification setting for active pharmaceutical ingredients (API), intermediates, starting materials and commercial drug products.
Writing of Specification (Justification) reports through consolidation of development and/or post-approval information from the JSC sites and from third party manufacturers. Critical evaluation and interpretation of files and data.
Advise technical teams on API and drug product control strategy, specification and analytical issues.
Answer questions, complaints, remarks or suggestions related to specifications from regulatory authorities and/or affiliates. Prepare and support Health Authority inspections and customer audits for assigned portfolio.
Ph.D. degree with 0 to 3 years or MS with 9 years of experience or at least 3 years of experience performing progressively advanced duties at the Senior Associate Scientist level.
Insight in chemical processes, product quality assurance/control, and product development and manufacturing is an asset.
High level understanding of global regulatory requirements and guidelines applicable to pharmaceuticals (small molecules), with the ability to apply cGMP regulations.
Ability to handle multiple tasks, respect commitments, as well as experience in working in cross functional teams is an asset.
Knowledge of English Language, both written and spoken is essential.
The pay grade for this position is 26. This position is located in Beerse, Belgium and can be filled immediately and is a temporary position for 1 year.
Janssen Pharmaceutica N.V. (7555)