Biogen

Full-time Region: EU+/Canada Department: Manufacturing Job Description About the role Location : Baar, CH as per local hybrid policy Business travel :Ability to travel domestically and internationally as needed. You will oversee technical and business operations at designated external manufacturing sites, serving as the primary point of accountability for strategic and tactical activities and be responsible for driving strategic initiatives for business growth and operational excellence. Responsible for up to 15 CDMO sites and up to $300m in spend, you will ensure supplier performance meets quality, cost, and delivery specifications, and be responsible for establishing and adhering to external manufacturing budget for designated sites. This role includes driving continuous improvements in efficiency, quality, and cost-effectiveness across manufacturing processes. You will establish and maintain strong partnerships with external partners to foster effective collaboration and long-term success. Leading cross-functional teams, you will address complex manufacturing issues and ensure compliance with regulatory requirements. You will be responsible for CDMO site selection, contract negotiation, and aligning manufacturing strategies with internal stakeholders. Your leadership will also involve liaising with governmental agencies as needed to uphold operational standards. Collaboration with the cross-functional stakeholders will be key in facilitating technology transfers and validations. You will lead a small team of direct reports. What you'll do Advocate for and represent a team of External Site Leads in global leadership teams and present high-level project risks, milestones, and stage gates to senior leadership. Collaborate globally with directors and managers of other line functions to ensure delivery of process transfers to the timelines required by the Asset Development Program Management Teams. Identify, define, and lead optimization projects resulting in improved (simplified, more robust, or clearer) business processes for external manufacturing technical operations. Directs the implementation of the agreed-upon solutions and is accountable for the effectiveness of new process(es). Cultivate continuous improvement environment within tech transfer teams at both internal and external sites. Understand and respond to global supplier cluster business priorities and translate these into tactical objectives. Ensures technical alignment of all functions within external manufacturing and PO&T for responsible Supplier cluster. Manage budget, staffing, and performance management duties for the team. Provide technical direction, leadership, and development to people leaders and individual contributors. Ensure compliance of external technical operations within with 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. Revenue Impact and Spend Oversight - ~$1.8 B in product revenue from products supplied through CDMO managed sites; ~$275M in spend to managed Qualifications Education: Masters or Ph.D. in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or closely allied discipline. Minimum 12 years of experience in biotech/pharmaceutical cGMP manufacturing industry. Experience with supplier relationship management. Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams. Strong negotiation skills. Strong technical proficiency within small molecule development and manufacturing is a must. Experience across modalities required. Ability to travel domestically and internationally as needed. Additional Information 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.

Full-time Region: US Job Description About This Role The Pharmaceutical Operations and Technology (PO&T) Division is looking to hire a Commercial Asset Lead. This Asset Lead is a member of the Asset Development & Portfolio Management (ADPM) team which provides cross-functional leadership across PO&T-s line functions for an asset. The PO&T Asset Lead is accountable for end-to-end asset leadership including asset strategy, development, supply and life cycle management planning for the commercial program. This PO&T Asset Lead role is specifically responsible for leading a commercial asset and all life cycle management activities. This is a hybrid role that could be based in Cambridge, MA or Baar, Switzerland. What You-ll Do Serve as the PO&T -asset owner- with accountability for delivering a 5-year PO&T Asset Strategy, maintenance of an 18-month rolling Tactical Plan, monitoring key program risks and development of risk mitigation plans Lead the cross-functional PO&T Asset Team (i.e., including representatives from each PO&T Line Function) in the development of and delivery on the PO&T Asset Strategy & Tactical Plan Serve as PO&T-s representative on the R&D Program teams and PDC teams; acts as in influencer and liaison between R&D, Commercial and PO&T in support on asset(s). Proactively manage conflicts with the Asset Strategy (e.g., driven by other Assets and/or Line Function priorities) in consultation with the PO&T Governance Committee. Ensure alignment and accountability of PO&T Line Functions for providing support for their needs balanced with the needs of the Asset Strategy. Monitor asset-related impacts on the P&L (e.g., COGS, E&O, OPEX) and collaborate with the PO&T Line Functions to develop tactics to improve them. Develop business cases for key Asset initiatives and secure management endorsement at the PO&T Governance Committee Qualifications Bachelor-s degree and a minimum of 12 years of relevant experience with a focus on matrix management. Advanced degree (MS, PhD, MBA) preferred in a relevant biopharmaceutical discipline Track record of effective matrix leadership experience in the setting of program teams across the full product life cycle, e.g., (CMC) PO&T line functions sub-teams or other cross-functional teams operating in a matrix environment ideally across an organization Experience with CMC, supply chain, or LCM development extending from IND to NDA/BLA, including a solid understanding of global registration processes. Technical expertise in a relevant biopharmaceutical development discipline Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., R&D, commercial, technical development, regulatory) Excellent strategic, political, organizational, and relationship development skills Demonstrated ability to lead, motivate, influence without authority a strategic direction; ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others. Excellent communication, negotiation, problem solving and decision-making abilities Demonstrated ability to identify critical program risks and develop mitigation plans - strategic or tactical to mitigate risk, costs, and reputation of Biogen. Who You Are You are a seasoned leader with in-depth experience in drug development, supply chain or manufacturing. You will be part of ADPM and lead teams representing PO&T disciplines and maintain critical partnerships with relevant program R&D and/or product commercial leaders. You will be instrumental in leading and facilitating key aspects of the PO&T vision including Influence & Collaborations through engagement with/oversight of collaborations and interface with BD and External Innovation; Data Access and Connectivity by driving best practices for resource management/forecasting decision gates and associated knowledge management initiatives. Additional Information 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. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Full-time Region: EU+/Canada Department: Manufacturing Job Description About This Role As our Mfg Scientist II Downstream Process transfer you will provide key technical subject matter expertise to Downstream process transfer & process sciences activities to support technology transfer & operations at the Solothurn Drug Substance manufacturing facility. Assignments may vary per overall MS team and site requirements. What You'll Do Lead cross-functional process transfer sub-teams for new product introduction, PPQ or restart campaigns. Provide support & technical leadership to operations by leading complex process related investigations, impact assessments, CAPAs & GCCs. Lead design and execute process science lab studies to support facility fit, campaigns, investigations, and innovation. Perform data analysis to support process science studies, process consistency and improvements. Author and review technical protocols & reports for process validation, investigations, process sciences studies and regulatory commitments. Translate and guide cross-functional stakeholders in process knowledge. Who You Are You are a highly experienced technical expert in downstresm drug substance manufacturing operations and process sciences. You excel in coordinating technical expertise and leading cross-functional project teams to align with strategic goals and site priorities. You are self-driven with the desire to make a positive impact to peers, processes & patients. Qualifications PhD, MSc or BSc in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or closely allied discipline. (BS with at least 8 years experience or MS with at least 4 years experience or PhD with at least 2 years experience). Deeply understands process descriptions and process control strategies. Masters process technology processes. Understands operational quality concepts and masters usage of quality management systems. Knowledgeable regarding manufacturing execution systems (Syncade and Delta V) Fully understands cGMP requirements and applies these requirements to all situations. Excellent investigational and writing skills. Communicates openly and honestly with others in both oral and written forms. Provides guidance and training to co-workers and supports team goals by example. English - minimum B1 Additional Information 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.