Head of Global Manufacturing Sciences, Plasma (Hybrid)

Company: Takeda Pharmaceutical
Location: Brookline
Posted on: November 18, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: Head of Global Manufacturing Sciences, PlasmaHybrid RoleReporting to Head of Global ManufacturingTravel - 20% - 30% depending on locationLocations: Cambridge, MASocial Circle, GeorgiaCHE, Glattpark ZurichWien, AustriaLessines, BelgiumRieti, ItalyAbout the role:The Head of Global Manufacturing Sciences Plasma leads a global multisite team of plasma scientists and process engineers providing support on solving issues affecting plasma products manufacturing. The Head of GMSci Plasma is responsible for defining and implementing the Plasma product Life Cycle strategy according to Plasma OpU including process and technology innovations, collaborate with PDT R&D process assessment and development for new products and novel technologies.The Head of Global Manufacturing Sciences Plasma will

• Member of the Plasma Leadership team and of the Global Manufacturing Science Leadership team.
• Manage a global multi-site team of senior experts located in different sites (US, EU, China) which provides technical leadership and coordination for commercial plasma products and inspire creativity and next-generation processes across the network
• Promote plasma manufacturing technology strategy and new ideas: improve and manufacturing capacity expansion; responsible for defining manufacturing and technology strategies to reduce cost of goods of top growing plasma products while driving process harmonization across the network
• Lead plasma related complex problem investigations and resolution: lead plasma related complex problem investigations and resolution (Rapid Response), technology transfer/scale-up of new/improved manufacturing process/unit ops PPQ and CPV's, process and product change control management, lead authoring of CMC submissions.
• Provide a technical operational interface with PDT R&D; ensure continuity and expansion of process knowledge through-out product lifecycle
• Increase supply chain security through definition of proper process validation strategies while providing accountability for technical oversight of CMC submissions. Support business due diligence, lead Tech transfer and manufacturability assessments/industrializations
• Coordinate work together with site management in a series of site based Manufacturing Sciences labsHow you will contribute:
  • Manage process changes with multisite and product impacts
  • Support Plasma OpU by defining and leading manufacturing technology strategies for plasma products portfolio
  • Accountable to develop long range forecast to meet yield commitments for products Lead technology transfer, process validation, CPV and manufacturing process change management among sites.
  • Increase supply chain surety with technical/statistical/6-sigma guidance to improve manufacturing process robustness and compliance
  • Develop and implement manufacturing process life cycle management plans for IgG, Albumin, A1PI, Ceprotein, pdFVIII, and FEIBA aligning with changing requirements/needs
  • Develop and implement process control strategy to reduce supply risks by visualizing state of control, process variabilities, deviations, and OOS through statistical and digital tools across sites to create global insight into the performance of the network.Technical/Functional (Line) Expertise
    • Broad end to end experience of plasma manufacturing processes (Last Liter and First Liter)
    • Use on technical know-hows and SMEs in the network for strategy development and building processes for and new ideas.
    • Establish a broad network of relationships throughout Takeda, affiliates, and alliance partners, in the industry and area of expertise.Leadership
      • Communicate convincing Plasma Manufacturing business cases for change that motivates team members to take action.
      • Create enthusiasm for Plasma Manufacturing activities by showing the connection between current state and the long-term benefits of the activity.
      • Cultivate a broad network of relationships throughout Takeda, with affiliates and alliance partners, in the industry and area of expertise.Decision-making and Autonomy
        • Attract and develop the technical, scientific and leadership expertise needed to build competitive advantage.
        • Create functional strategies and goals that are aligned with Takeda's goals and develop metrics to track and assess performance.
        • Develop concise, strategic plans based on a clear understanding of our strengths, weaknesses, opportunities, and threats.
        • Continue to strengthen team applying on methodologies, data analytics, statistics, scientific and engineering principlesInteraction
          • Create a clear and unifying vision that inspires the team to excel.
          • Achieve results by managing the right combination of diverse people, resources, and processes.
          • Build teams across departments and geographies with individuals who have the right experience to achieve important organizational projects.
          • Identify opportunities and anticipate changes in the business landscape through an understanding and ongoing assessment of Plasma Manufacturing project plans.Complexity
            • Understand differences in practices across organizations and countries, and balance local demands and perspectives with global strategies.
            • Create an environment that promotes information exchange, expression of opinions, thoughts, and beliefs.What you bring to Takeda:
              • A bachelor/master's degree in chemistry, chemical engineering, biochemistry, biotechnology or pharmaceutical engineering or related fields.
              • 16+ years professional & leadership experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry biotechnology
              • Minimum of 11+ years in a Manufacturing Science role with increasing responsibilities
              • Background in/knowledge of plasma is necessary
              • Experienced people manager, working in a matrix organization, connecting teams with each other
              • Experience with change management projects and processes
              • Knowledge of 6 Sigma and Statistical knowledge
              • Experience within the GMP environment, and regulatory affairs
              • Excellent communication skillsWhat Takeda can offer you:
                • Comprehensive Healthcare: Medical, Dental, and Vision
                • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
                • Health & Wellness programs including onsite flu shots and health screenings
                • Generous time off for vacation and the option to purchase additional vacation days
                • Community Outreach Programs and company match of charitable contributions
                • Family Planning Support
                • Professional development opportunities
                • Tuition reimbursementImportant Considerations:At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
                  • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
                  • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
                  • Work in a cold, wet environment.
                  • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
                  • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This posting excludes Colorado applicants.#GMSGQ#ZR1#LI#Pharma#PharmaceuticalEEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsLexington, MABEL - Lessines, ITA - Rieti, USA - CA - Los Angeles, USA - GA - Social Circle - Hwy 278, Vienna, Austria, Zurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Brookline , Head of Global Manufacturing Sciences, Plasma (Hybrid), Other , Brookline, Massachusetts