Director, Small Scale Manufacturing

About This Role

Reporting to the Site Head/GM of RTP Bio Site Operations and a critical member of the Site Leadership Team, you will be responsible for establishing and maintaining total control, accountability, and ownership of critical manufacturing operations in our Small Scale (2000L) & Flexible Volume (1000L) factory areas. You will communicate strategic goals to all levels of staff, focusing on overall execution, regulatory compliance, and effective collaboration with all functions supporting the manufacturing plant. You will also be charged with setting the overall direction, coordination, and evaluation of employees in the individual manufacturing teams within the department(s) you oversee and be responsible for administering Biogen’s applicable policies and procedures. People leadership responsibilities include interviewing, hiring and training employees, planning, assigning, and directing work, appraising performance, driving continuous improvements to business systems, rewarding and disciplining employees, addressing complaints and resolving employee-related problems.

What You’ll Do

• Lead the group of people panagers and overall staff in the Small Scale Manufacturing (SSM) & Flexible Volume Manufacturing (FVM) factories in goal attainment and achievement of KPI’s (Key Performance Indicators), focusing on the details
• Review and edit key regulatory documents to support drug compliance and process improvements
• Develop and coach the area supervisors as they focus on personal and team development
• Ensure prioritization by the operational teams on Safety, Quality, Delivery, Engagement, and Cost
• Review HR issues and staffing concerns to best support team progress and effectiveness
• Represent manufacturing operations for inter-site, interdepartmental meetings, and regulatory / internal / partner inspections
• Collaborate with support and partner groups to reach mutually agreed-upon deadlines
• Manage process changes to support overall cGMP compliance.
• Conduct briefings and participate in technical meetings for senior management and external representatives concerning specific operations
• Report potential operational risks and issues to senior management and lateral operational managers
• Fulfill other job duties that may be assigned from time to time
• Direct and control the activities of the area shift teams through other manufacturing supervisors who have overall responsibility for the successful operation of their assigned areas
• Review and assess CI decisions and proposals for regulatory changes for possible implementation
• Review state of operations from fiscal overview to area walk-throughs

Who You Are

You are an experienced leader with a passion for managing a team in a GMP environment focused on drug substance manufacturing. You are goal driven and possess phenomenal leadership skills.

Qualifications

Required Skills

• The normal working hours of this position are 8 hours per day on a fixed schedule and designated shift. Typically, this position is on-call during off hours on weekdays, weekends, or non-scheduled workdays. Typically, this position is required to work under time pressure. The position is responsible at all hours to address issues and batch processing demands, which require department head review.
• Vast knowledge of cGMP’s and direct experience in inspections conducted by various regulatory inspection agencies such as EMEA and FDA
• Minimum of 12 years of related experience and/or training (Biologics / Drug Substance Manufacturing); and/or an equivalent combination of education and experience
• Bachelor’s Degree (BA/BS) from a four-year college or university with an emphasis on Biotechnology, Life Sciences, and/or Engineering
• Demonstrated track record of continuous improvement to operational systems and business processes in manufacturing areas
• Comfortability having frequent contacts with internal personnel and outside supplier representatives at various management levels concerning strategic operations or scheduling of specific phases of important projects or contracts.
• At least 6 years of experience supervising employees in a Biotech manufacturing environment

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.