CMC Lead QDenga
USA - 3387 BioLife Plasma Services, LP
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Job Description
How you will contribute:
- Responsible for CMC strategy to enable effective lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process knowledge, capability & improvement, tech transfer, and process validation
- Aligns with Global Product team on CMC LCM strategy
- Drives the link between CMC strategy on the Global Product team and CMC execution on the CMC subteam
- Ensure harmonization/ standardization between facilities and best practice sharing
- Accountable to guarantee proper yield tracking and to provide accurate yield status and forecast
- Drive Yield projects identification, scoping, prioritization, tracking and reporting
- Is the overall product / process expert for the product; provides bridges across expertise represented on the CMC team
- Accountable for CMC sections of product dossiers
- Provide SME expertise of major process and methods investigations
What you bring to Takeda:
- Degree in engineering or life sciences
- Experience operating globally in a matrixed organization highly preferred
- Must be self-motivated, have good interpersonal and communication 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
Locations
Zurich, SwitzerlandBase Salary Range:
CHF177,400.00 - CHF243,980.00For information about our benefits, please click here.
Worker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeSummary
Lead CMC strategies, ensure process optimization, compliance, and global product lifecycle management.
Job title
CMC Lead QDenga
Experience level
professional level
Industry
pharmaceuticals
Location requirements
Zurich, Switzerland; on-site; no remote work
Salary
$177k–$244k
Visa sponsorship
H-1B sponsor history
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Zürich, Switzerland