Basic qualifications:

•BSc (or equivalent) in a related scientific or technical discipline, such as chemical engineering, chemistry, pharmacy or materials science & engineering

•Minimum of 5 years industrial experience in pharmaceutical, nutritional (or FMCG) manufacturing and / or product development

•Understanding and knowledge of quality systems, future approaches and regulations

•Competent in all Unit Operations associated with the API/product and understands the impact of material changes on manufacturability

•Knowledge of the structured problem solving approaches used for all product & process issues

Details:

•Be the named person accountable for the 'well being' of a product or product family. ‘Well-being’ encompasses hands-on knowledge of the equipment, manufacturing process & the product critical quality attributes (CQAs) and critical process parameters (CPPs)

•Manages technology transfer for respective products from R& into GMS and subsequent transfers to other sites.

•Influences the manufacturing process / analytical process / pack / device and associated specifications throughout the product lifecycle.

•Supports standardisation of manufacturing and analytical technology across sites engaged in manufacture of common dose forms (e.g. via Manufacturing Excellence Forums)

•Understands the key interactions between raw materials and equipment during dosage form manufacture and the resulting transformations

•Ensures the critical process parameters (CPPs) of the dosage form or API are known, understood, controlled and verified

•Ensures the critical quality attributes (CQAs) of the dosage form or API are known, understood, controlled and verified

•Coordinates the Technical Risk Assessments in support of Design for Manufacture and Change Management

•Trends product performance and acts on process drift (including stability)

•Provides leadership (directly or indirectly) to a relevantly skilled technical team on all technical aspects of that API/product manufacture

•Works with the end-to-end supply chain to optmise the technical performance of allocated API/ products within manufacturing

•Establishes and chairs the Product Technical Review Teams (PTRT) for new products

•Liaises with other Product Owners, including counterparts in Primary/Secondary, to share and capture best practices (local/regional/global as required)

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