CMC Operations Lead, Small Molecules (Hybrid)応募後で応募 求人ID R0094067 掲載日 04/17/2023 Location:Boston, Massachusetts
Job Title: CMC Lead, Small Molecules - Senior Manager
Location: Cambridge, MA (Hybrid)
About the role:
- Build, develop, motivate and lead a global team of experts responsible for CMC life cycle management for Takeda’s small molecule portfolio
- Acts as a focal point to drive manufacturing technology excellence for Takeda’s small molecule portfolio
- Provides strong direction in prioritization of life cycle management and technology excellence activities to optimize resource utilization given competing requirements across the small molecule portfolio
How you will contribute:
- Provide strong direction to CMC Leads to drive effective life cycle management for Takeda’s commercial small molecule portfolio
- Provide strong leadership for initiatives which are complex or span across multiple products
- Lead a small team within GMSci small molecule to work across other GMSci organizations, internal and external manufacturing sites, and Pharmaceutical Sciences to define directions for technology excellence and innovation including digital solutions and data analytics
- Drive effective communication for group activities across the organization including leading regular reviews of product and method performance, continuous improvement plans, and experimental approaches, to lead global process-related change controls or initiatives and to perform the global reporting of process performance.
- Lead 1 – 2 CMC teams
- Provide leadership and guidance to the team through data gathering
- With information available/provided, able to lead the team to a satisfactory direction with proper guidance
Technical/Functional (Line) Expertise
- Has understanding of small molecule manufacturing, the regulatory environment, life cycle management
- An enterprise manager balancing and aligning goals and priorities to meet company objectives
- Ability to influence broadly within the organization to drive decisions, alignment, and conflict resolution for complex cross-functional CMC and technology excellence issues
- Work closely with the associated PMs for each program to drive to the success of the CMC team
- Being a mentor developing future leaders
- Provides vision and passion for driving technology and innovation within the small molecule portfolio
- Able to operate effectively through ambiguity
- Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality into the organization
Decision-making and Autonomy
- Able to make appropriate decisions based on guidance from organization management and lead the team toward completing the tasks based on the decisions made.
- Works across GMSci small molecule organization (including API and DP) to align CMC LCM activities within the various GMSci functional organizations
- Works across GMSci global functions as needed for business metrics and align on LCM procedures
- Works across GMSci small molecule (API and DP), Pharmaceutical Sciences, and Site Manufacturing Sciences groups to align on vision and priorities for LCM and Technology Excellence.
- Works with the GMSci LCM group on coordination of hand-off of late stage products to the commercial team
- Scope includes innovation in manufacturing equipment, manufacturing processes, and use of digital technology to provide data-driven approaches
- Manages with a matrix of reporting lines and across functional areas
- Provides leadership to drive highly complex projects involving cutting across multiple sites and products
What you bring to Takeda:
Education / experience
- A bachelor degree in engineering or life sciences
- 5 years experience in pharmaceutical development and manufacturing
- Experience operating globally in a matrixed organization highly preferred
- Experience defining the strategy and roadmap for complex, cross-functional initiatives
- Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
- Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust
- Creating the environment that inspires and enables people
- 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
- 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. 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.