CMC Senior Project Lead, Global Biologics Manufacturing Sciences
Listed on 2025-12-18
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Manufacturing / Production
Manufacturing Engineer, Quality Engineering
CMC Senior Project Lead, Global Biologics Manufacturing Sciences
Join us as our CMC Sr. Project Lead in the Global Biologics Manufacturing Sciences (GMsci Bio) and play a pivotal role in advancing our biologics portfolio. In this role you will provide project management expertise for strategic initiatives and Chemistry, Manufacturing and Controls (CMC) Life Cycle management (LCM) activities, utilizing technology platforms to efficiently gather project data and deliver actionable insights through effective visualization and reporting.
HowYou Will Contribute
- Co‑lead CMC project teams for complex biologic products and guide CMC teams with the CMC lead.
- Lead Global Technology Transfer Projects.
- Ensure timely execution of CMC LCM strategies to maintain supply continuity, risk management, and global launch execution.
- Make data‑driven decisions to optimize project plans.
- Develop cross‑functional plans, oversee project budgets, and estimate resources for successful project completion.
- Apply agile principles to streamline business processes and enhance organizational capacity.
- Mentor and develop project management talent within the organization.
- BS/MS in engineering, life sciences, or related field.
- Minimum of 5‑year experience within a CMC‑related environment.
- Strong background within biotech or pharma industry.
- Expert in Microsoft 365 and PM tools (MSP, Smartsheet, etc.).
- Strong knowledge of Agile, Lean, DMAIC, Waterfall, PMBOK methodologies.
- Strong grasp of organizational development and cross‑functional alignment.
- Fluent English required;
Mandarin proficiency beneficial. - Confident in timely reporting and escalation.
- Proficient in project infrastructure.
- Previous experience in global matrixed organizations with Asian cultural acumen beneficial.
- Proven experience leading global and local cross‑functional teams with effective communication and collaborative approach.
- Understanding of technical dimensions of regulatory submissions and tech transfer with previous experience in both.
USA – MA – Hayden – 45–55
U.S. Base Salary Range: $ – $
U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision, 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well‑being benefits. U.S. based employees are also eligible to receive up to 80 hours of sick time, and new hires accrue up to 120 hours of paid vacation.
EEOStatement
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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