Haleon is looking to hire a Technical Product Owner to effectively and independently own and lead all elements of the Product Lifecycle for the site's products, ensuring product quality and process robustness.
Requirements
- Detailed knowledge of relevant dosage forms including unit operation understanding, functionality and criticality of formulation materials and their transformations (e.g. powder technology, colloid science, crystallization, isolation, drying and particle size reduction), plant equipment and analytical testing.
- Awareness of device/packaging processes.
- Level 1 Facilitator for TRAs (‘Proficient’ level as defined by the TRA competency framework)
- Capability to develop basic materials and formulation science input into RCAs (criticality and functionality of materials) and TRAs (particle science and formulation expertise).
- Knowledge of regulatory environment, particularly in markets where product is commercialized.
- Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities
- Able to evaluate potential innovative technology areas relevant to product
Responsibilities
- Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality CQAs) and critical process parameters (CPPs).
- Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s), including cleaning of products: Technical, Product Control Control Strategy to standard work as batch manufacturing instructions as per the principles), Continued Process Verification and Process Robustness Assessment.
- Ensures QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialization of new products from R&D, and subsequent transfers to other sites.
- Maintains accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach for the product.
- Responsible for assessing the product quality impact of any change that can impact CQCQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of primary changes impacting API material properties (primary product owner), assessment of impact of API/excipient changes on the dose secondary product owner), via the Material Risk Assessment process (MRA), PLC/recipe control system changes, valve design changes etc
- Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
- Provides technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
Other
- 5+ years' experience in a process, manufacturing, project, or R&D engineering position
- Experience in Pharmaceutical/FMCG or other regulated industry
- Experience working in a manufacturing environment, including manufacturing process and equipment.
- Thorough knowledge of GMP and EHS requirements
- Demonstrated in-depth knowledge of Quality by Design and risk management approaches
