Production Lead, External Manufacturing

Production Lead, External Manufacturing

• Full-time
• Region: EU+/Canada
• Department: Manufacturing

Job Description

About the role

Potentially under the coordination of a Virtual Plant Manager, you manage manufacturing operations for specific product(s) at one or more contract manufacturing organisations (CMOs) . Responsibilities include commercial and/or clinical supply. Here you participate to one or several virtual plant teams. Manage a subset of product(s) with one or more CMOs.

You are responsible for direct communication with contract site on production and production issues.

You are expected to work closely with internal Biogen groups, and to coordinate the corresponding virtual plant team(s) (Quality, Planning, Logistics, Sourcing, Manufacturing Sciences, and Technical Development). Here you ensure continued supply of API / Drug Product / Finished Product as per clinical and/or commercial demand.

For products under responsibility, this role ensures projects (product lifecycle management, technology transfers, change control etc.) are smoothly implemented at the CMO and in coordination with concerned Biogen functions.

Location: Baar, Switzerland working as per local hybrid HR policy

The function requires frequent international travel to the contract manufacturing organisations in scope of the position.

Technical experience in drug product and/or drug substance manufacturing required.

What you'll do

• For products under responsibility, participates to organization of the cross-functional virtual plant teams consisting of representatives of External Manufacturing, Planning, Logistics, Quality, Manufacturing Sciences and ad hoc members. Leads execution of virtual plant team meetings for products under responsibility. In this role, and for products under her/his responsibility, ensure alignment of PO&T functions (members of virtual plant teams) and CMO to assure:
• On time and in full delivery of clinical and commercial products;
• Prevention and resolution of operational issues e.g. deviations, corrective and preventive actions, production delays etc.;
• Alignment of production planning with planned CMO production;
• Follow-up of change control timely implementation in line with regulatory and stock management constraints;
• Other operational aspects.

2. Leads the CMO governance team for products under her/his responsibility:

• Monitor site performance according to standard KPIs;
• Support metrics targets setup with CMO based on governance team’s input
• Support bringing CMO(s)’ performance / maintaining it to Biogen’s expectations;
• Identify quality / technical / business / EHS risks and related mitigation and corrective actions;
• Ensure implementation of such actions at CMO(s) and Biogen;

3. Participate to or lead other matrix teams to drive projects, both internally and externally as they relate to the relevant API, Drug Product, device assembly or labelling and packaging operations.

• Such projects include technology transfers, process improvements, validation activities, packaging changes, regulatory submission reviews etc. and associate change management and/or project management.

4. Act as backup to the Virtual Plant Manager.

Qualifications

• Bachelors/Master Degree (Life Science, Quality, Engineering), additional competences in Business Administration, Supply Chain or related fields are a plus.
• Minimum 2 years of experience In biotech/pharmaceutical cGMP manufacturing industry. Experience with supplier relationship experience is a plus.
• Technical experience in drug product and/or drug substance manufacturing required.
• Some experience in project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams.
• Ideally, experience with either biologics and oral solid dosage manufacturing including a mix of parenteral filling, API, oral solid dosage and finished products manufacturing.
• Good negotiation skills.
• Fluent in English

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