For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

JOB SUMMARY

Reporting to the Site Director, the Associate Director, Biomanufacturing Operations is responsible for managing a cross functional work cell team that provides for the manufacture of drug substance and drug product. The Associate Director is responsible for ensuring that all staff is appropriately trained and follows the appropriate SOPs. This role will work closely with the Site Director and Manufacturing Leadership Team to ensure manufacturing activities are fully supported. This role will also work closely with Tech Transfer and Manufacturing Leadership to assess incoming processes and advise site leadership and business development on compatibility of incoming technologies and manufacturing facility.

• Participate in overall account governance, facilitate leadership review as required.
• Provide strategic context for objectives and decisions to team, senior leadership, and the broader organization as appropriate
• Drive collaboration with internal cross-functional teams necessary for delivery on the project including Process Sciences, Manufacturing Sciences & Technologies, Quality Control, Quality Assurance, Supply Chain to ensuring alignment on project objectives and priorities.
• Facilitate internal project team meetings and external client meetings including delivery and management of a project objectives, meeting agendas, integrated project schedules, key performance measures, risk registrar, timely meeting minutes & action items.
• Assist in development of budget and budget planning, forecasting, etc
• Assist in strategic planning and development of projections for business needs required to meet production goals
• Advise and inform leadership of any potential impacts to production, production timelines, or CQA
• Build, train, and develops highly skilled teams by identifying opportunities for improvement, coaching/mentoring reports towards growth, and provided goals and challenges to stretch capabilities
• Oversees and approves nonconformance investigations, including root cause analysis, and CAPA development

JOB QUALIFICATIONS

• A minimum of a BS in science or engineering or advanced degree (MS preferred), with at least 7 years of biologics manufacturing experience or equivalent cGMP experience is required
• A minimum of 5 years cGMP manufacturing leadership experience required
• Exhibits exceptional leadership skills and deep knowledge of GMP
• Possess effective written and oral communication skills
• Demonstrates initiative to remain apprise of relevant industry and regulatory trends

• Participate in overall account governance, facilitate leadership review as required.
• Provide strategic context for objectives and decisions to team, senior leadership, and the broader organization as appropriate
• Drive collaboration with internal cross-functional teams necessary for delivery on the project including Process Sciences, Manufacturing Sciences & Technologies, Quality Control, Quality Assurance, Supply Chain to ensuring alignment on project objectives and priorities.
• Facilitate internal project team meetings and external client meetings including delivery and management of a project objectives, meeting agendas, integrated project schedules, key performance measures, risk registrar, timely meeting minutes & action items.
• Assist in development of budget and budget planning, forecasting, etc
• Assist in strategic planning and development of projections for business needs required to meet production goals
• Advise and inform leadership of any potential impacts to production, production timelines, or CQA
• Build, train, and develops highly skilled teams by identifying opportunities for improvement, coaching/mentoring reports towards growth, and provided goals and challenges to stretch capabilities
• Oversees and approves nonconformance investigations, including root cause analysis, and CAPA developmen