Location: Cambridge, MA
in Biogen's GMTO function. In this role, you will manage overall manufacturing responsibilities across the portfolio, technical transfer of processes and methods (both Biogen internal assets and strategic partner programs run in Biogen) into internal factories and external CDMO plants, including (in differing proportions of shared accountability with Development, depending on modality) early clinical programs, late-stage/PPQ, and commercial programs going to new sites.
Deploys GMS technical TT leads, technical product leads, process SMEs, Process Sciences labs/scientists, Materials Sciences lab/scientists, and data analytics scientists to ensure new campaign success; materials and consumables
suitability for use; supplier technical readiness; tools for campaign, batch, and materials visibility; process troubleshooting and correction; and development and implementation of lifecycle process improvements for commercial assets.
You will also ensure that new processes, materials, control technologies, and monitoring approaches and tools are manufacturing-ready in a phase-appropriate/stage-gated manner. MAIN RESPONSIBILITIES With broad accountability in driving the shared goals of GMTO and PO&T, this leader sits on the Senior Leadership Team (SLT) for GMTO and provides insight and recommendations to guide and set the strategy for the overall GMTO organization and interacts with/presents
to the PO&T SLT as needed. In this role, you must also maintain a degree of visibility to tactical considerations and issues that relate to or impact clinical and commercial processes, as well as the transfer of processes into internal factories and external plants.
You will partner collaboratively with peers and leaders in the other PO&T line functions to ensure that GMTO is ready to both receive and execute new processes/products, and to ensure that new technologies for process and plant are robust, implementable, and sustainable in a manufacturing environment. You will serve on joint steering committees for major strategic partners. As a leader of GMS, the role is highly impactful to GMTO operations and to the success of PO&T's assets: this team's work ensures successful timelines for starting and completing clinical and PPQ campaigns in high run-rate plants and CDMOs; technical support during clinical and commercial campaigns; timely investigation and correction of manufacturing process issues; and contribution to and review of key sections of regulatory filings for new assets.
Ensures that late-stage processes are ready for process validation, and owns and drives the process validation master plan, protocols, and reports. The Materials Science team ensures vendor technical readiness for raw material and consumables supply to Biogen and provide raw materials analytical characterization and monitoring to look for " unknowns" before materials are committed to GMP batches.
The site teams provide expert process support as needed for Operations, both internally and externally. Also, they provide technical management of strategic partner relationships, including tech transfer and batch/campaign/issue visibility for partners. Directs direct reports (GMS Leadership Team) to ensure success in meeting PO&T's strategic goals and Asset Team timelines and milestones.
Sets strategy and goals of GMS to align with GMTO and PO&T and responds agilely to new asset acquisition and partner opportunities as they arise. Ensures that GMS site and global line functions are working in a matrixed framework to drive the needs of internal asset timelines, strategic partner program timelines, and GMTO. Partners with leadership in Global Engineering, Manufacturing, ADPM, Quality, and Regulatory Affairs to ensure that cross-functional teams are working smoothly to deliver and maintain processes and controls that are timely, phase-appropriately ready for manufacturing, and compliant, to meet clinical and commercial Supply Chain needs.
Understands and responds to business priorities and translates into tactical objectives and work direction for the site MS teams. Includes the direct and matrixed GMS team listed above. Ensures that production schedules and Asset Program deliverables are not compromised due to tech transfer/process transfer issues, partnering with the other GMS line functions as required. Manages budget (~$22MM OPEX, ~$2.5MM CAPEX yearly), staffing, and performance management duties for GMS. Mentors direct and indirect reports on development planning and possibilities for their careers, both within GMS and across Biogen.
Ensures compliance of investigative activities across modalities within the GMS team with c Gx P regulations and maintains a high degree of regulatory compliance with FDA, EMA, and other agency guidelines and regulations to ensure solid data packages and data-integral reports for filings. Responsible for relevant CMC sections of clinical and commercial product regulatory filings. Provides technical SME support during site regulatory inspections, both from directly reporting staff at the inspection site and from the matrixed GMS line functions.
Responsible for overall process validation process monitoring and CPV to ensure process robustness and to identify process improvements inclusive and exclusive of LCM opportunities. Improvement plans to drive year over year soft and hard savings across the organization. Qualifications The ideal candidate will be an established leader in this space and will have led and motivated teams. Professional Qualifications A minimum of 15 years' experience in a biomedical/medical manufacturing environment with at least 8-10 years of senior management experience.
Education: Degree in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or closely allied discipline; Ph. D. in relevant fields is preferred. Deep technical and scientific competencies across multiple modalities. Demonstrated success in managing, motivating, and continually strengthening a large, complex, and multi-disciplinary organization. High complexity of challenges and decision-making requirements - management of a multi-line team that covers all phases of GMP operations, internally and externally, across all modalities in which Biogen works.
Demonstrated capabilities in transforming and modernizing a sizable operation by appropriately leveraging standards and technology and innovative end-to-end thinking. Ability to build, convincingly communicate and execute strategic and operational plans for a global function. Strong ability to prioritize and deploy resources across the organization rapidly to respond to changes in schedule, shifts in modality needs, and operational surprises, and at the same build business models for major areas of accountability for GMS so that the delivering team can apply standard work as much as possible for efficient use of resources.
Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy. Exceptional leadership skills, with the ability to communicate vision, set direction, as well as inspire, motivate, and mentor a cross-functional team. Ability to travel as needed both domestically and internationally Must be able to work on campus 2-3 days a week Personal Characteristics A proven ability to operate effectively in a rapidly changing environment where analytical skills and agility are equally as important; a strategic thinker who is operationally focused who can manage diverse agendas and personalities Self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and thrives in a dynamic environment as a leader influencing change and transformation Credible and savvy business person who is well networked across the industry and will be perceived as a trusted consultant and functional expert to senior management.
Must be an influential advisor; bold and courageous while having the antennae to understand cultural and political nuance Knowledgeable in leading-edge security business practices, trends, and information; aware of strategies and tactics being applied in the marketplace that are innovative Able to engender trust and respect quickly as a manager of people, with a priority on staff development.
A capability builder at both the organizational level as well as the individual level An individual of unquestioned personal and business integrity who will be viewed as trustworthy both within the company, as well as with external relations A mission-driven individual with high energy and high levels of perseverance; works towards both individual and team goals Additional Information All your information will be kept confidential according to EEO guidelines.
Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. 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 interaction, gender identity or expression, interactionual 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. PDN-9aab8b8c-2ad6-44c0-9c5f-781fc74d2ab3For more details: jobs-search. org/manufacturing_cambridge-c434666/head-of-global-manufacturing-sciences-cambridge_i1959027829
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