Director, Technical Services Manufacturing Science

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The Director, TSMS is responsible for all technical aspects of product and process performance at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The role is responsible for maintaining and improving the scientific oversight of the manufacturing processes and technical changes, and to ensure the product stewardship across process units and functions. In direct collaboration with Manufacturing Operation units and other functions (Quality, Engineering, IT, etc.)

the Director, TSMS provides clear direction and the necessary expertise to:
Ensure the robustness of manufacturing and packaging processes so that all products and processes are maintained in an appropriately validated state of control throughout the product lifecycle. Support and where appropriate lead optimization of biopharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technology strategies.

• Ensure that the technical competencies/knowledge for the site’s monoclonal antibody processes, raw materials, sterile processes, and primary packaging components are in place (as applicable).
• Coaches and develops TSMS Team members to identify strengths and weaknesses and grow the technical ability of the team.
• Advises, guides and coaches TSMS associates for the purpose of ensuring routine operational support, identifying solutions and improvement, solving problems, decision making and communication including quality of written reports.
• Ensures adherence to cGMP requirements, guidelines, SOPs, as well as compliance to local laws, the Elanco Red Book, company policies and Health Safety & Environment (HSE) requirements.
• Particular attention is given to the protection of employees, patients, company assets and the environment.
• Ensure that mAb products and processes are in control and capable, with appropriate control strategies in place to meet Elanco Global Quality and Manufacturing standards and maintain continuity of supply.
• Develop and lead continuous improvement initiatives which positively impact cycle time, productivity, process robustness, gross margin, and production capacity.
• Partner with Commercialization, R&D, Manufacturing, Engineering, Supply Chain and Quality to successfully in-transfer new mAb products.
• Ensure that transfers are accomplished on-time, with appropriate process / product control strategies in place.
• Leads cross-functional teams for root cause investigations.
• Committed to knowledge sharing/transfer inside site manufacturing groups as well as to Technical R&D (TRD).
• Drives the product control strategy including development and application of KPIs to enable meaningful CPP/CQA trending and reporting of key process data as well as to…