Associate Director, Biosimilars Integration & Manufacturing Optimization External Manufacturing

Job title: Associate Director, Biosimilars Integration & Manufacturing Optimization External Manufacturing

Job description: Associate Director, Biosimilars Integration & Manufacturing Optimization External Manufacturing

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

Job Description

• You will participate to due diligence activities in relation biosimilar products.
• Together with network strategy and sourcing, you will define a strategy for an external network for biosimilar production and works with sourcing to implement strategy
• In addition you will act as primary contact and relationship manager to specified Contract Manufacturing Organization(s) for the entire relationship. For CMO(s) under her/his responsibility, and in connection with the CMO’s upper management and Biogen representatives of other technology platforms, this includes:

· Managing contract setup, negotiation and maintenance (in collaboration with the Sourcing team);

· Define budget in collaboration with the concerned asset teams as well as with the Manufacturing Science or Technical Development teams, based on anticipated new product transfers, process improvements or other significant projects;

· Manage budget for contracted activities, including negotiation of initial and revised prices;

· Establishing and/or maintaining the appropriate level of relationship;

· Managing and solving potential disagreements, contract breaches etc.;

· Assuring that interfaces between Biogen and CMO processes are functional and efficient.

· Interacts with strategic partnership function for partnered programs

4. For CMO(s) under your responsibility, you will lead the cross-functional virtual plant teams consisting of representatives of External Manufacturing, Planning, Logistics, Quality, Manufacturing Sciences and ad hoc members. In this role, assure:

· On time and in full delivery of clinical and commercial products by coordinating the work of the virtual plant team (QA, Release, MS / TD, Planning, Logistics, QC, Engineering etc.) to analyse the performance of the different processes (manufacturing, planning, ordering, release, change control etc.), aligning on improvement actions and assuring their implementation;

· For clinical products, align Technical Development and CMO processes and expectations;

· Resolution of operational issues e.g. deviations, corrective and preventive actions, production delays etc.;

· Alignment of production planning with planned CMO production;

· Ownership of change control timely implementation in line with regulatory and stock management constraints;

· Monitoring site performance according to standard KPIs;

· Negotiate metrics targets with CMO based on governance team’s input

· Bringing CMO(s)’ performance / maintaining it to Biogen’s expectations;

· Identifying quality / technical / business / EHS risks and related mitigation and corrective actions;

· Ensure implementation of such actions at CMO(s) and Biogen

· Run Management Reviews between the CMO’s and Biogen’s management teams, as well as annual Partnership strategic meetings between the CMO’s and Biogen’s upper management team (up to SVP or EVP level at Biogen), aligning both organisations on long term strategic partnership.

· Establish governance across platforms, and ensures consistency between different business units of the CMO where applicable

· As part of the relationship manager responsibilities, serves as escalation point to the CMO for all activities performaned by the CMO, regardless of the modality (e.g. Drug Substance and Packaging activities).

5. Depending on the extent of the portfolio managed by the concerned CMO(s), the holder of the position may coordinate the work of one or more Production Leads, and/or virtual plant managers without direct management responsibility.

6. You will 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.

7. In addition you will act as backup for the Head of Drugs Substance External Manufacturing

Qualifications

· Bachelors/Master Degree (Life Science, Quality, Engineering, Business Administration or a related field)

· Minimum 10 years of relevant experience in supply chain / manufacturing operations

· Experience working in a GMP regulated environment.

· You will have demonstrated management skills.

· You would have gained project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams.

· You have gained experience managing project budgets

· Experience with manufacturing of biologics products (drug substance and fill-finish)

· You will be fluent in English

Additional Information

In scope of Biogen’s strategic initiative to develop its Biosimilar Products portfolio you will lead the external supply-related aspects of due diligence activities for new target biosimilars: coordinate the evaluation of existing manufacturers’ technical capabilities, regulatory competences, quality level, production capacity, supply-related processes, financial viability etc. Together with network strategy and sourcing, he/she develops and implementes an external network for biosimilars that meets demand needs with cost-efficient, high quality supply of biosimlar products.

The successful candidate works with crossfunctional team to define platform processes for biosimilar drug substance and drug product and establishes corresponding CMO network. In addition you will act as virtual plant manager for assigned CMOs.

You will report to Head of Drug Substance External Manufacturing and be based in our Int. Headquarter in Baar.

Company: Biogen

Expected salary:

Location: Canada

Job date: Thu, 13 May 2021 01:13:04 GMT