Production lead - Pharmaceutical Products (Small Molecules)

Under the coordination of a Virtual Plant Manager, manages manufacturing operations for specific product(s) at one or more CMOs. Responsibilities include commercial and/or clinical supply. Participates to one or several virtual plant teams. Manages a subset of product(s) with one or more CMOs.
Is responsible for direct communication with contract site on production and production issues.
The position holder is 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). Ensures continued supply of API / Drug Product / Finished Product as per clinical and/or commercial demand.
For products under responsibility, ensures projects (product lifecycle management, technology transfers, change control etc.) are smoothly implemented at the CMO and in coordination with concerned Biogen functions.
The function required frequent international travel to the contract manufacturing organizations in scope of the position.
Act as backup to the Virtual Plant Manager in charge of concerned CMO(s).

1.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 labeling 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 for operational aspects.

Minimum 2 - 5 years of experience In biotech/pharmaceutical cGMP manufacturing industry. Experience with supplier relationship experience is a plus.
Some experience in project leadership skills and ability to develop effective working processes and relat

Under the coordination of a Virtual Plant Manager, manages manufacturing operations for specific product(s) at one or more CMOs. Responsibilities include commercial and/or clinical supply. Participates to one or several virtual plant teams. Manages a subset of product(s) with one or more CMOs.