Director, Technical Services Manufacturing Science

• ◆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).
• ◆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 quickly identify changing quality trends and issues.
• ◆Develop the expense and capital planning budgets for the TSMS function in collaboration with the Sr. Director, Commercialization and site leadership team. Ensure TSMS delivery meets or exceeds financial commitments.
• ◆Responsible for the design and delivery of TSMS owned technical training programs as well as appropriate technical on-boarding to ensure competency of TSMS associates.
• ◆Stays abreast of technological, regulatory and industry developments, e.g., via internal and external benchmarking.
• ◆Build and grow the TSMS function, recruiting and developing talent in alignment with the site’s strategic needs.
• ◆Maintain a safe work environment and establish a strong safety culture in compliance with Elanco standards and all applicable government requirements.
• ◆Ensure TSMS staff operate in accordance with all applicable Quality and cGMP requirements. Accountable for quality performance of the function and delivery against site quality targets.
• ◆Develop and review operational objectives with direct reports, establish appropriate talent development plans, and conduct staff performance management reviews as required.
• ◆Other duties as required.

Minimum Qualification (education, experience and/or training, required certifications) :

• ◆Bachelor’s degree in a biomanufacturing related discipline (e.g. biology, Chemistry, engineering, etc.).
• ◆10 years of related working experience
• ◆5+ years’ experience in technical management position.
• ◆5+ years’ experience in (bio)pharmaceutical formulation, process development, or manufacturing technology.
• ◆Ability to lead and develop a team.
• ◆Fundamental understanding of (bio)pharmaceutical analytical testing.
• ◆Demonstrated understanding of Q culture, cGMP standards, and regulatory regulations.