Job Description
Primary Objective
The Sr. Manager External Manufacturing Biologics will provide leadership for the development/ manufacture of Drug Substance and Commercial Supply Operations. This role will be responsible for overseeing the scale-up, manufacturing, deviations, changes and troubleshooting, along with any process validation activities. They will be also responsible for the overall (end to end) commercial supply of the biologics products globally.
Major Duties/Responsibilities
Lead the operational activities at DS CMO's, overseeing scheduling and manufacturing of DS for commercial supply.
Serve as DS Subject Matter Expert (SME) on multidisciplinary CMC teams to ensure scientifically driven development and optimization of DS manufacturing process.
Review and approve master batch records, change controls, and deviations, CAPA to ensure GMP compliance and operational success.
Preparation and review of documents such as technical reports, validation documents, deviation reports and regulatory modules as required.
Assist in development of specifications for raw materials, consumables, process intermediates and drug substance.
Plan and prepare forecast of the commercial supply and supply the product to global markets on time and in full.
Keep track of quality, quantity, stock levels, delivery times, transport costs and efficiency
Maintain metrics and analyse data to assess performance of service providers and implement improvements
The candidate will communicate across the organization to ensure key stakeholders are aware of project status, potential risks and their required action plans.
Other duties as assigned
Education
BS, MS or Ph.D. degree in (bio) chemical engineering, biotechnology, biochemistry or biology.
Professional Experience
Doctorate degree and 3-5 years of related experience - or- Master's degree and 4-7 years of related experience - or- Bachelor's degree and 6-10 years of direct experience in Biologics process development and manufacturing
Knowledge and experience in animal cell culture processing and purification processes
Knowledge of Business process, project management and operational excellence experience.
Knowledge of analytical testing methods and impact on product quality specifications is advantageous.
Think strategically to assess and improve processes to meet business needs globally.
Ability to diagnose complex issues; develop and implement solutions by collaborating with other teams.
Ability to lead teams and be able to influence internal and external stakeholders.