Operations Services Lead, Manufacturing
About This Role
The Operations Services Lead holds the accountability for a dedicated area within manufacturing, overseeing a specialized operational unit responsible for transversal activities across Biologics Manufacturing Centers (BMCs). This role includes managing key processes such as cells amplification steps at Inoculum stages, BDS filling, column packing, along with essential general services activities. Duties involve technical oversight and the management of personnel, driving efficiency gains and staff development while reducing production costs. Leading issue resolution associated with batch disposition and ensuring global alignment with other manufacturing sites are crucial aspects of this role.
What You'll Do
- Strategic Planning: Establish manufacturing strategies, organizational goals, and implement ongoing improvements in business processes.
- Operational Innovation: Manage the functional area and drive innovation by evaluating efficiency gains, leveraging technology to minimize human error, and enhance efficiency in the manufacturing process.
- Technical Representation: Act as a process and technical expert for the designated area, representing Manufacturing in cross-functional teams.
- Regulatory Compliance: Ensure adherence to corporate policies and regulatory standards. Develop and evaluate technical and cGMP training programs for the team.
- Team Leadership: Recruit and develop high-performing teams while fostering a culture of compliance and continuous learning.
- Safety and Compliance: Ensure 100% compliance with EH&S standards for the team and yourself.
- Integrated Working Teams: Lead the establishment of Integrated Working Teams to drive a cohesive and borderless working environment.
Who You Are
You're a problem-solving expert with a wealth of experience in developing innovative solutions. Your strength lies in decision-making and judgment, guiding you to resolve complex issues effectively and implement optimal problem-solving techniques.
- Education and Experience: HS Diploma and 11+ years of experience, or BD preferred with 7+ years in a GMP environment.
- Proven people management and development skills, particularly in fast-paced environments.
- Thorough knowledge of basic QA and cGMP principles.
- Ability to resolve complex problems, exercising independent judgment and evaluation criteria.
- A strong focus on continuous improvement and operational excellence.
- Excellent verbal and written communication skills, exceptional interpersonal abilities.
- Proven ability to resolve conflicts and negotiate solutions with diplomacy.
- Project Management: Strong organizational and project management skills, including prioritization adjustments.
- Understanding and implementation of empowerment, driving decisions to the lowest possible level.
- Willingness to understand the job at all levels within the organization and inspire staff for career growth within Biogen.
- Good understanding of Manufacturing Systems such as DeltaV, Syncade, SIMCA, PI, Oracle, and TrackWise.
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
