Director S&t Analytical Sciences (all Genders)

Ludwigshafen am Rhein, Germany

Job Description

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.


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At our Ludwigshafen Site we\'re looking for a Director S&T Analytical Group (all genders) who takes full time dedicated responsibility for leadership and management of an analytical organization to support CMC development of commercial and pipeline products. The role owner plays a key leadership role within Operations, Science and technology (S&T), Analytical Sciences Department.


Responsibilities:

  • Responsible for S&T Analytical department strategy development to position the organization to meet increasing AbbVie business needs in product development and commercial supply
  • Manage a group of analytical scientists who are responsible for multiple development projects. Managerial responsibilities include people training and development, performance management, project assignments, and resource balance
  • Manage analytical project teams in Germany and other EU locations to support global development teams for new product introduction and commercial product life-cycle -management activities
  • Provide technical leadership in managing project teams and guiding the analytical project leads to develop analytical strategies, execute the project plans, and deliver results in method development, validation and transfer, specification setting and justification, analytical investigations, assisting manufacturing sites to resolve analytical issues, regulatory filing, and inspection preparation, and supporting new product launch
  • Proactively advise and share knowledge/expert opinions with the group, peers and management. Promote and participate in active network of consortia and other external collaborations
  • Establish close collaboration between analytical and other CMC functional areas to provide support to drug substance and drug product development and maximize contributions to projects by analytical teams
  • Closely collaborate with R&D in late-stage analytical method development, validation and transfer, support manufacturing activities to achieve commercial readiness. Additionally, build strong alliance with R&D in advancing analytical technology and its implementation at AbbVie
  • Support global quality control labs in analytical investigations, troubleshooting in method execution, method remediation, and provide other technical assistance
  • Play a liaison role between S&T Analytical and commercial manufacturing facilities in EU and world-wide
  • Lead innovation by encouraging ideas for continuous improvement and initiatives within work group, supporting scientific exploration, bringing in new analytical technologies or data analytic tools, and implementing new approaches to enhance organizational capacity, such as risk-based stability, laboratory automation, process monitoring technologies or data analytics
  • Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer reviewer for submissions
  • Lead cross-functional CMC teams for development projects
  • Coach analytical chemists in the group for professional advancement

Qualifications
  • Bachelor’s Degree with 14+ years of relevant experience (CMC, small molecule manufacturing/development); Master’s Degree with 12+ years of relevant experience; and PhD Degree with at least 10+ years of relevant experience is preferred
  • Analytical development experience in pharmaceutical industry is required
  • Demonstrated track record in managing successful analytical organizations
  • CMC development experience from early stage through NDA/MAA
  • Advanced knowledge and experience in analytical technologies and instrumentation required
  • Technical understanding and experience with small molecule products manufacturing, development, and control strategy is preferred
  • Knowledge and experience with FDA and global regulatory requirements in CMC area is required
  • Ability to influence internal and external experts on CMC regulatory issues, independently
  • Demonstrated excellence in writing, presentation, and overall communication
  • Demonstrated excellence in analytical chemistry experience in pharmaceutical product analysis

We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.

An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.

Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.



Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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Job Detail

  • Job Id
    JD1804418
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Vollzeit
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Ludwigshafen am Rhein, Germany
  • Education
    Not mentioned