Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Lead Process Scientist, Drug Product in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- 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 needed
- 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
- Implement 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
- Implement the manufacturing strategy for key Takeda products at internal manufacturing network and CMOs
- Acccountable 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 above leadership for 1 2 Takeda key products
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- BS or graduate degree in Chemistry, Chemical Engineering, or other related discipline with 10+ years of industrial experience or equivalent.
- Minimum 5 years experience in pharmaceutical development and manufacturing
- Previous experience in serving as a SME lead in a matrix environment relating to drug product manufacturing
- Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
- Focusing on the few priorities and provide superior results
- Elevating capabilities for now and the future
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- 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
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.