Job Description

 

This functional leader requires specialized knowledge and expertise in their job discipline and deep experience in integrating related disciplinary knowledge.  Leader will be responsible for intermediate complexity CDMO sites, site could be larger or have higher program breath but should be operationally efficient and not in frequent hyper care.

 

Technical and Manufacturing Execution Leadership: This functional leader will have strong technical expertise on pharmaceutical / biologics manufacturing and will be responsible for the process control strategy and tactical execution of manufacturing operations for a specific modality and/or manufacturing node at an external supplier site/plant. He/She will be responsible for analyzing scientific datasets, providing technical and operational oversight towards manufacturing operations, managing global change controls and deviations, creating, updating, and communicating technology transfer deliverables and all applicable project metrics at external sites Biogen partners with, as well as authoring/reviewing site-specific Continuous Process Verification (CPV) reports. He/She must be able to solve complex manufacturing and compliance issues, develop, implement and execute corrective actions (CAPAs) and proactively identify/lead business process optimization opportunities and drive towards implementation. This individual will collaborate with senior leadership (internally and externally) as well as cross-functionally across all layers to ensure alignment and delivery of manufacturing objectives and will lead continuous improvement initiatives aimed at enhancing efficiency, quality, and cost-effectiveness within their respective manufacturing operations responsibility.Supplier Relationship Management: This person will bring leadership and display external relationship management expertise having worked with CDMOs and/or CLOs in pharmaceutical and/or medical device manufacturing, from site selection (RFx activities) through contract negotiation and execution, as well as, conducting business performance reviews and managing partner governance. This position will functionally lead the primary vendor engagement team (Person-In-Plant – where needed) and be accountable to drive and monitor supplier performance.Collaboratively, cross-functionally and inclusively defining scientific scope and driving innovative development projects and organization technology milestones.  Responsible for (as appropriate) leading, facilitating, or coordinating all activities pertaining to tech transfer, which includes initial process/facility fit, process control strategy transfer, manufacturing readiness, the production and testing, material disposition, and interacting with supplier sites.Act as a technical resource for a respective modality and/or node, including project schedule, TT plan, risks and mitigation tracking, and appropriate escalation within the relevant internal/external networks.Ensure compliance of external technical operations within 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.Lead supplier relationship management activities from contract development - to execution - to delivery - to metrics readout as well as governance execution.  Owning the vendor team engagement with partnership/sponsorship of the GM.

QualificationsTechnical subject matter expert in modality/node corresponding to manufacturing site designation.Exposure across all role requirements for Operations and Supplier Relationship Management.Education (Minimum): Bachelors > 10 years, Masters > 8 years, PhD > 5 years

Additional Information

This functional leader requires specialized knowledge and expertise in the manufacture of biologics and deep experience in integrating related disciplinary knowledge. It follows, that this role requires a solid technical understanding of the process control strategy for a specific modality and/or node as well as expertise in analyzing scientific data sets with strong analytical and written skills. This position requires the ability to drive to impactful and thoughtful decisions, act with a relevant sense of urgency, combine technical depth with project management discipline, manage conflict constructively, and work well in both an individual contributor and functional leadership capacity. Relevant expertise in influencing cross functional teams and providing clear direction to deliver on process and partnership priorities.  Ensuring efficient resolution to complex technical project management issues in a cross functional and multi-cultural environment in a manner that is compliant with regulatory expectations and Biogen’s business procedures. Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification. Excellent communication and project management skills for leading with internal and external teams. Desired expertise on external CDMO management, governance, contracting, and relationship management.

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.