Associate Director, Process Scientist (Cambridge, MA - Hybrid)

Company: Takeda Pharmaceutical
Location: Medford
Posted on: September 20, 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 Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Job Title: Associate Director, Process Scientist (Hybrid)Location: Cambridge, MA About the role:

• Provide technical expertise within the GMSci DP/Pkg organizations relating to manufacturing technology and sciences for drug product manufacturing.
• Serves as the SME for leading major technical transfer or validation projects relating to new product introduction or life cycle management of existing products
• Provides leadership for regulatory interactions including CMC content for dossiers
• Ensures process knowledge is shared and leveraged across sites and functions
• Serves as Takeda s global DP SME for issue resolution as neededHow you will contribute:
  • Serves as Takeda s expert on small molecule OSD or parenterals process and technologies
  • Lead the following activities, along with Pharmaceutical Sciences and/or Operation Units:
    • Drug Product Manufacturing Process Characterization,
    • Technology Transfer to both CMOs or internal manufacturing facilities,
    • Drug Product manufacturing and packaging process validation
    • Serves as the experts for deployment as rapid response teams to serve all local manufacturing Operating Units
      • Manage projects within Takeda product portfolio, both development and commercial, to support Manufacturing Sciences DP and Packaging Science activities (Commercial experience a plus)
      • Implement or provide input for strategies for the continuous improvement on the manufacturing of Marketed Products (a.k.a. matured products) in the late phase of the product life cycle
      • Accountable for successful collaboration with
        • Other functions within GMS
        • Manufacturing Operating Unit Site leads
        • Local Technical Services functions
        • Pharmaceutical Sciences counterparts
        • Other key functional groups such as Global Quality, Regulatory CMC, etc.
          • Provides leaderships for multiple (5 to 6) Takeda key products.
          • SME for Takeda drug product manufacturing organization and network
          • Knowledge of industry s best practice and innovative/emerging technology with manufacturing of drug product
          • Able to independently make complex and key decisions impacting drug product manufacturing organizations
          • Active engagement with development product implementation prior to commercialization to ensure successful commercialization of key Takeda products.
          • Actively partner with local Technical Services lead to ensure consistent application of best technology practices across Takeda network
          • Manages with a matrix of reporting lines and across functional areas
          • Provides leadership to drive highly complex projects including that span multiple sites and products
          • 10% - 25% travel (domestic and/or international)What you bring to Takeda:
            • BS or graduate degree in Chemistry, Chemical Engineering, or other related discipline with 15+ years of industrial experience or equivalent.
            • Minimum 10 years experience in pharmaceutical development and manufacturing
            • Previous experience in serving as a SME lead in a matrix environment relating to drug product manufacturingWhat 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 training and development opportunities
              • Tuition reimbursement 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. 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.EEO Statement Takeda 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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Medford , Associate Director, Process Scientist (Cambridge, MA - Hybrid), Executive , Medford, Massachusetts