Associate Director, Vaccines Drug Product Technical
vor 1 Woche
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a
_Associate Director, Vaccines Drug Product Technical Operations (M/F/d)_ for our Vaccines Business Unit, based in Zurich (Switzerland) or Singen (Germany).
Here, you will be a vital contributor to our inspiring, bold mission.
Associate Director, Vaccines Drug Product Technical Operations (all genders):
Objectives:
In this role you will provide technical expertise and leadership within the tetravalent Dengue vaccine formulation and fill-finish activities.
Supporting our external and internal manufacturing to remain operational, continuously improve, and innovate you will assume broad responsibility for tech transfers, process qualification and validation at drug product manufacturing sites.
Drug product, diluent and packaging process transfers, at scale studies, PPQ, process monitoring, and continuous process improvements are key focus areas for the role.
The role assignment has high level of exposure to and interaction with other functional areas supporting late-stage development, product life cycle management and commercial operations in a matrix organization.
Your Accountabilities:
- Represent technical operations in crossfunctional teams for engineering, qualification and validation and process knowledge of new and existing vaccine manufacturing facilities, processes, technology transfers
- Partner with crossfunctional stakeholders (PM, Development, QC, QA, Supply Chain, Regulatory, etc.) to enable tech transfer, startup of new product lines, scale up and PPQ
- Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams
- Conduct technical transfer as well as support lifecycle management planning & development from a manufacturing and scientific point of view
- Proactively anticipate, evaluate, and resolve technical challenges, major deviations, rootcauseanalysis, corrective action preventive action (CAPA) and support related change control processes with strong focus on quality, risk mitigation and regulatory compliance
- Ensure manufacturing processes, facilities, equipment, raw materials, cleaning methods, etc. are qualified and where needed validated and maintained in a state of compliance with all GMP and global health regulations
- Support writing and review of process manufacturing documentation as well as relevant sections for regulatory submissions
- Support process for management of data and analysis of various operational parameters, including Continuous Process Verification (CPV) and Annual Product Review (APR)
- Build partnerships in the areas of engineering and process equipment to drive awareness of new technologies for bestinclass manufacturing operations
- Provide scientific and technical support of commercial manufacturing at internal and external sites to support corporate goals for supply strategies
- Assist to guide and further develop a team of process engineers supporting both projects and commercial manufacturing in external and internal sites
Your Profile:
- Bachelor degree in life sciences / engineering or in a related area. Advanced degree (MS or PhD) preferred
- Solid experience tech transfer, and/or sustaining cGMP for drug product processes in manufacturing of biopharmaceuticals
- Experience working with vaccines and especially live viruses vaccines is a plus
- Scientific and technical knowledge regarding single use materials, formulation processes, aseptic filling, isolator technology, lyophilization, visual inspection and packaging
- A selfstarter 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 crossfunctional team experience
- Flexibility and the ability to work independently as well as excellent organizational skills
- Demonstrated ability to effectively communicate with his team but also at all levels of the organizations
- Willingness to travel
- Ability to maintain discipline on working time management under a hybrid working arrangement
- Excellent command of English (both written and oral), German language knowledge
WHAT TAKEDA CAN OFFER YOU:
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work.
Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health-
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