Takeda Pharmaceuticals Senior Manager Process Scientist in Boston, Massachusetts
Job Title: Process Scientist, Senior Manager - Global Manufacturing Science Drug Product
Location : Cambridge, MA
About the role:
Provide technical expertise within the GMSci Drug Product Packaging 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
How you will contribute:
Serves as Takeda’s expert on small molecule OSD or parenteral 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
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
Provide input the manufacturing strategy for key Takeda products at internal manufacturing network and CMOs
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.
Senior Manager level
- Provides above leadership for 1 – 2 Takeda key products
Technical/Functional (Line) Expertise
SME for Takeda drug product manufacturing organization and network
In depth and solid understanding of drug product manufacturing technologies for solid oral dosage form or injectable products
Knowledge of industry’s best practice and innovative/emerging technology with manufacturing of drug product and of industry’s standard practices
Ability to influence within the organization, specifically with Pharmaceutical Sciences, GMS Operating Units and CMOs to drive decisions, alignment, and conflict resolution for complex cross-functional issues
Effectively communicate and implement innovative and emerging technology for drug product within the Manufacturing Sciences organization
Able to communicate and influence decisions of Pharmaceutical Sciences development organization
Decision-making and Autonomy
- Make decisions impacting the organization upon consultation with senior management
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
Ensures process knowledge sharing across sites and functions for effective management of products
Maintain current industry leading technology knowledge, scientific approach and regulatory strategies
Ability to drive and implement of innovative technology at Local Technical Services organizations
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
What you bring to Takeda:
Education / experience
BS or graduate degree in Chemistry, Chemical Engineering, or other related discipline
Minimum 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:
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
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.
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.
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