Manager Manufacturing Science and Technology Drug Substance
Vor 3 Tagen
About the Role:
We are seeking a highly skilled and experienced professional to join our team as a Manager Manufacturing Science and Technology Drug Substance. As a key member of our organization, you will be responsible for providing scientific and technical leadership and/or support of commercial Qdenga Drug Substance manufacturing at external partners and/or internal Takeda site.
Main Responsibilities:
- Provide scientific and technical leadership and/or support of commercial Qdenga Drug Substance manufacturing at external partners and/or internal Takeda site to support corporate goals for Qdenga supply strategies, productivity, quality, and compliance.
- Provide ongoing technical and technical leadership and oversight for change control, deviation investigations and CAPA management as required during development, technology transfer, process validation and commercial manufacturing
- Partner with internal and external stakeholders communicate, escalate and resolve program issues both within Takeda and with external manufacturing partners
- Working cross-functionally, develop robust proposals for life cycle management changes and technology transfer of vaccine Drug Substance manufacturing processes
- Partner with engineering to provide process inputs for process fit assessments and to define process requirements for new manufacturing facilities.
- Represent Manufacturing Science & Technology Drug Substance in cross-functional teams for engineering, qualification and validation of new and existing vaccine manufacturing facilities / processes and technology transfers
Requirements:
- BS with minimum of 3-5 years of experience in start-up, technology transfer, and sustaining cGMP for biopharmaceutical drug substance manufacturing processes. Experience with viruses is a plus.
- Scientific and technical knowledge across the variety of up-stream and down-stream processing unit operations in biopharmaceutical manufacturing, including usage of single-use technologies.
- A self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of structured product development
- Proven ability to efficiently work with and/or lead cross-functional teams in a and business functions in a matrix environment.
- Able to lead and manage technical teams, serve as a partner and influence others. Demonstrated cross-functional team experience.
- Willingness to travel
- German language considered a plus
About Takeda:
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people, and the planet.
What We Offer:
- Open-minded and modern working environment
- Hybrid working model
- 30 vacation days
- Company pension plan
- Further education and training
- Attractive Relocation Package including brokerage fees
- Subsidized canteen
- Subsidized sports programs
- Disability insurance
- Long-term account with various possible uses
- Employee discounts
- Employee Stock Purchase Plan
- Company accident insurance
- Performance-related bonus
- Trusted working hours
- Employee Referral Program
- Deferred compensation as desired
- Global Wellbeing Program
- Interactive online courses for employees' children
- Employee Recognition Program
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