Job Detail

Job Description

1.        Responsible for PO&T Strategic Relationship Management between Biogen and alliance partner. Serves as single point of contact for GMTO for products in scope of joint venture towards Biogen commercial Biosimilar Business Unit (BBU) and alliance partner, and drives the partnership forward for supply chain & Manufacturing

Liaise with the heads of internal Biogen groups, ensures internal alignment, and facilitates effective and efficient processes and communication between Biogen PO&T groups and the alliance partner

2.      Lead the cross-functional virtual plant team for Drug Substance, Drug Product and Assembly consisting of representatives of External Manufacturing, Planning, Logistics, Quality, Manufacturing Sciences and ad hoc members. In this role, assure that the team performs to achieve:

• On time and in full delivery of Biosimilar partner products;


• 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.

3.        Lead the governance forum between Biogen and the alliance partner

• Identify decisions required for Supply Chain and External Manufacturing (incl. escalation from D&OP and CMO business management reviews)


• Review Launch Related Activities (as required)


• Identify & review Program Issues, Metrics, and Potential Quality & Compliance Issues (as required)


• Define key priorities to drive the partnership between Biogen and the alliance partner related to Supply Chain & External Manufacturing


• Own improvement initiatives for Supply Chain and External Manufacturing         

4.        Ensure that the 2-way processes between Biogen and the alliance partner, as well as the 3-way processes between Biogen, the alliance partner and Contract Manufacturers are functional and efficient (e.g. monitoring performance, resolving potential misalignments, ensuring on-time & in-full delivery of products).

Ensure projects (product lifecycle management, technology transfers, change control etc.) are effectively implemented in coordination between Biogen, the alliance partner, and CMO (as applicable).

5.        Keep oversight over the contractual agreements and obligations between Biogen and the alliance partner related to Supply Chain & Manufacturing. Participate to due diligence and sourcing activities in relation to the partnerships as required.

6.        Manage a team of Virtual Plant Managers and Production Leads, with overall responsibility for outsourced production of biosimilars and potentially also originator products.  As such, develop people, sets expectations, delegate appropriately, conducts performance evaluation and coaching.

7.        Participate to or leads other matrix teams to drive projects and strategy building, both internally and externally as they relate to the relevant API, Drug Product, device assembly or labelling and packaging operations. management.

8.        Act as backup for the Head of  parenteral platform  External Manufacturing.

Qualifications

• Master Degree or more in Life Science, Quality, Engineering, Business Administration or a related field


• Minimum  10 years of experience in supply chain / manufacturing operations


• Experience with supplier relationship management


• Experience working in a GMP regulated environment


• Good knowledge of biologics manufacturing processes (DS, DP, FG)


• Business acumen, ability to build supply strategy to align commercial and supply / manufacturing short and long term goals


• Demonstrated management skills


• Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams


• Excellent negotiation skills


• Experience managing project budgets


• Demonstrated team management skills (direct and matrix reports).


• Ability to align expectations with asset management teams, Commercial organization and launch teams.

Additional Information

• This role requires ability to comprehensively understand commercial dynamics and industry trends as well as supply chain, manufacturing, financial & contractual requirements related to the Biosimilars partner products. The holder of the position also needs to be able to negotiate resolution of potential contractual conflicts or shortfalls between the two companies, negotiating with department heads (VPs, SVPs) and come to a resolution that maintains the collaborative relationship between partners.


• Ability to anticipate long term manufacturing, supply chain and related budgetary needs, to negotiate their implementation, as well as to quickly solve operational problems related to production, planning, logistics, quality, technical aspects. Analyses and improves high level processes aiming at timely production and supply of Biosimilars products. Drives the alliance partnership forward, and is able to define, negotiate and implement mid & long term shared objectives to improve the partnership. Leads the governance forum consisting of VPs and SVPs of both companies and runs management reviews.