- PLCM change coordinator of GCC and Artwork for Biogen commercial products. Responsibilities also include oversight of Drug Substance (DS) and Drug Product (DP) global change control impacting Finished Goods (FG) for a brand in growth phase.
- Ensures alignment of artwork with the technical requirements needed for production on a packaging line at a CMO. As part of this, understands the technical limitations and liaises with key stakeholders on solution, next steps, and mitigation.
- Oversee process interdependencies across the End-to-End Supply Chain and collaborates with Planning, Regulatory Sciences, and Regulatory CMC to ensure that change control and labeling changes align with the FG & DP supply plans, while achieving on-time closure.
- Develops and executes cross-functional project implementation plans for GCC and Artwork, ensuring activities across PO&T departments are aligned and sustained in line with KPIs. This may involve collaboration with the following key stakeholders: Master Data Management, Quality, Regulatory CMC, Manufacturing, Serialization, D&L, and Regulatory Sciences.
- Leads cross-functional analysis and drives process improvement and sustainability for the GCC and Artwork process, ensuring standard practices, processes and procedures.
- Leads, executes and project manage GCC and Artwork changes and DS/DP changes impacting Finished Goods (FG) for Biogen commercial products under leadership of the PLCM product portfolio leader. Collaborate with internal and external Subject Matter Experts (SMEs) for on time execution of changes, with overall impact to the OTIF metric.
- Leads development of the Artwork and GCC planning for a product and market to liaise with internal and external stakeholders, including vendors and CMOs, to ensure alignment of artwork with technical requirements and GCC assessment.
- Engages or leads continuous improvement projects to drive process standardization and operational efficiency. Perform Artwork/GCC process analyses and identify potential improvement projects.
- Collaborates with Quality to promote and maintain compliance via exception & CAPA management, while driving on-time closure
- Bachelor or comparable degree in Supply Chain Management, Business Administration, Engineering or similar education required
- Lean Six Sigma/Green Belt is an asset
- Minimum 1 year working experience in a Global Supply Chain, Artwork or GCC role
- Experience within an international and controlled environment is required
- Must have strong GMP/GXP Skillset.
- Strong analytical, problem solving and communication skills
- Knowledge of printing technologies, artwork creation software, pre-press activities and CMO line manufacturing is an asset.
- Experience with Supply Chain and LCM tools, preferably: Oracle, TrackWise, Agile PLM
- Influencing and negotiation skills to attain buy-in from different stakeholders
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Beschreibung
About the role
Location Baar
What you'll do
Who you are
Strong analytical, problem solving and communication skills. Influencing and negotiation skills to attain buy-in from different stakeholders.
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.
