Manager - Pharmaceutical Drug Manufacturing - Supply Chain Technical Operations

Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: March 19, 2023

Job Description:

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummarySupport the manufacturing of products across the Daiichi Sankyo network and CMO's. Support the efficient transfer of products and technology from product development to commercial stage and continue support throughout life cycle management of both manufacturing and packaging sites. Work closely with internal technical and quality groups to assess existing manufacturing/packaging issues and changes.

Responsibilities

• Plays a critical role in supporting manufacturing and packaging projects including the existing portfolio as well as future oncology projects across Daiichi Sankyo and CMO sites. Operates as manufacturing and packaging technology expert interfacing with Pharmaceutical Technology, QA, RA and commercial supply functions to ensure sustainability, scalability, and production readiness of manufacturing and packaging processes. Support the development and review of key Supply and Technical agreements. Support the implementation of long-term capacity, risk mitigation, and performance improvement plans.
• Act as US commercial technical liaison to Pharmaceutical Technology Group on new product development and re-formulation projects. Ensure the requirements for product engineering work are properly detailed and the essential deliverables are identified. Participate as commercial CMC representative on Global Project Teams (GPTs), provide ongoing process support, and contribute to the technical development on appropriate sections of regulatory filings.
• Responsible for the planning, initiation, implementation and execution of large projects involving product portfolio. Responsibilities include:
  
  • Defining the project charter, roles, tasks, milestones, budgets and measures of success.
  • Developing project plans to manage the end-to-end project activities and the execution approach (e.g., specifying goals, strategy, and staffing, scheduling, identification of risks, issues resolution, contingency plans, communication plans, change control, and allocation of available resources).Responsible for the execution and delivery of projects. Responsibilities include:
  • Drive deliverables and milestones to meet base line and current plan dates.
  • Schedule, lead and facilitate project team meetings.
  • Working with team leads, functional managers and project support staff to create, maintain and manage the project schedule.
  • Provide project progress, status reporting and presentation for executive management and stakeholders.
  • Maintain and manage project budgets.
  • Support QA on change controls for products after PPQ phase has been completed. Assist RA in life cycle management for US approved products.Competencies:
    • Strong communicator with excellent interpersonal, analytical, and problem solving skills.
    • Experience with biologics manufacturing
    • Proven ability to work across multiple projects effectively and gain consensus on cross-functional teams.
    • Builds productive partnerships both internally and externally.
    • Ability to adapt to dynamic changes in priorities, resources, and deadlines.
    • Demonstrated ability to apply technology solutions to business problems.
    • Knowledge of regulatory requirements and guidance-particularly cGMPs.
    • Demonstrated ability to operate in a diverse group within a multicultural environment.
    • Flexibility to new thinking and innovation.
    • Proficient with Microsoft suite of software packages.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)
      
      
      • Bachelor's Degree In Life Sciences, Pharmacy, Biotechnology, Chemical Engineering or related filed required
      • Master's Degree In Life Sciences, Pharmacy, Biotechnology, Chemical Engineering or related filed preferred
      • PhD preferredExperience Qualifications
        
        
        • 1-3 or more years of Management experience in the pharmaceutical or biotech industries. Experience should include process development, manufacturing operations, fill/finish production support, process transfer, scale-up, and troubleshooting. High level of knowledge of FDA GMP practices and regulations required
        • 3 or more years of experience managing and delivering cross-functional projects across multiple technologies. required
        • 1 or more years of experience executing strategies in a global environment. preferred
        • Managing a product launch or major manufacturing transfer preferredTravelAbility to travel up to 30% Business TravelDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Keywords: Daiichi Sankyo, Inc., Newark , Manager - Pharmaceutical Drug Manufacturing - Supply Chain Technical Operations, IT / Software / Systems , Basking Ridge, New Jersey