General Manager, Fill Finish

Posted 19 Hours Ago
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Baar, Zug
Senior level
Biotech
The Role
The General Manager, Fill Finish oversees technical and business operations at multiple external manufacturing sites, managing budgets and driving strategic initiatives for business growth and efficiency. Responsibilities include supplier performance oversight, compliance with regulations, leading cross-functional teams, and fostering partnerships with external stakeholders.
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Job Description

About the role

Location Baar, Switzerland as per local HR hybrid policy

Travel: Ability to travel domestically and internationally as needed. 

You will oversee technical and business operations at designated external manufacturing sites, serving as the primary point of accountability for strategic and tactical activities and be responsible for driving strategic initiatives for business growth and operational excellence. Responsible for up to 5 CDMO sites and up to $100m in spend, they will ensure supplier performance meets quality, cost, and delivery specifications, and be responsible for establishing and adhering to external manufacturing budget for designated sites. This role includes driving continuous improvements in efficiency, quality, and cost-effectiveness across manufacturing processes. You will establish and maintain strong partnerships with external partners to foster effective collaboration and long-term success. Leading cross-functional teams, they will address complex manufacturing issues and ensure compliance with regulatory requirements. You will be responsible for CDMO site selection, contract negotiation, and aligning manufacturing strategies with internal stakeholders. Your leadership will also involve liaising with governmental agencies as needed to uphold operational standards. Collaboration with the cross-functional stakeholders will be key in facilitating technology transfers and validations. You will lead a small team of direct reports.


What you'll do

  • Advocate for and represent a team of External Site Leads in global leadership teams and present high-level project risks, milestones, and stage gates to senior leadership. Collaborate globally with directors and managers of other line functions to ensure delivery of process transfers to the timelines required by the Asset Development Program Management Teams.
  • Identify, define, and lead optimization projects resulting in improved (simplified, more robust, or clearer) business processes for external manufacturing technical operations. Directs the implementation of the agreed-upon solutions and is accountable for the effectiveness of new process(es). Cultivate continuous improvement environment within tech transfer teams at both internal and external sites.
  • Understand and respond to global supplier cluster business priorities and translate these into tactical objectives. Ensures technical alignment of all functions within external manufacturing and PO&T for responsible Supplier cluster.
  • Manage budget, staffing, and performance management duties for the team. Provide technical direction, leadership, and development to people leaders and individual contributors.
  • Ensure compliance of external technical operations within with both Biogen procedures and cGXP regulations and guidelines. Ensure that all external manufacturing protocols and reports are compliant with both agency expectations for their respective locations and modalities. 
  • Revenue Impact and Spend Oversight 

Who you are

Experience with supplier relationship management. Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams. Strong negotiation skills. Strong technical proficiency within fill and finish development and manufacturing is a must. Experience across modalities required.

Qualifications

  • Education: Masters or Ph.D. in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or closely allied discipline. 
  • Minimum 12 years of experience in biotech/pharmaceutical cGMP manufacturing industry.
  • Experience with supplier relationship management.
  • Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams.
  • Strong negotiation skills demonstrated in prior roles
  • Strong technical proficiency within fill and finish development and manufacturing is a must 
  • Experience across modalities required.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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.

The Company
HQ: Cambridge, MA
9,575 Employees
On-site Workplace

What We Do

Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.

Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.

With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

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