Manager, Vaccine Technical Operations応募 後で応募 求人ID R0012371 掲載日 09/13/2019 Location:Cambridge, Massachusetts
The Manager, Vaccine Technical Operations will be responsible for:
- Providing technical oversight support as required for sterile process operations being carried out at Takeda’s network of manufacturing partners
- Supporting implementation of manufacturing and quality systems (such as change controls, deviations, etc.) in collaboration with internal and external partners.
- Working with Development and Operations Teams to plan and manage process improvements, scale-up, technical transfers and life-cycle management.
- Developing and implementing manufacturing solutions to enhance quality, cost and robustness of vaccine manufacturing processes
- Provide scientific and technical support of commercial manufacturing at partners to support corporate goals for supply strategies, productivity, quality, and compliance.
- Provide ongoing technical support for change control, deviation investigations and CAPA management as required during development and commercial manufacturing
- Partner with internal and external stakeholders communicate, escalate and resolve program issues both within Takeda and with external manufacturing partners
- Partner with engineering to provide process inputs for process fit assessments and to define process requirements for new manufacturing facilities.
- Working cross-functionally, develop robust proposals for scale-up and technology transfer of vaccine products, and for life-cycle management changes.
- Lead cross-functional teams for engineering, qualification and validation of new and existing vaccine manufacturing facilities / processes and technology transfers
- Build partnerships in the areas of engineering and process equipment to drive awareness of new technologies for best in class manufacturing operations.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS with a minimum of 5 years’ experience or MS with a minimum of 3 years’ experience in start-up, tech transfer, and/or sustaining cGMP for commercial sterile process operations in vaccines or biopharmaceuticals.
- Scientific and technical knowledge regarding CIP/SIP, formulation processes, aseptic filling, isolator technology, lyophilization and visual inspection.
- Demonstrated expertise in process transfer for drug product operations, including formulation/filling, lyophilization and/or visual inspection
- Experience in single use technologies, and the ability to manage vaccine-specific nuances and strategies. Experience working with live viruses is a plus
- 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 work with efficiency across multiple project teams 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.
- 20% domestic and international
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.