Senior Technical Manager- Pharmaceutical Sciences- Wilmington, DE
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. In Operations we have a big ambition - to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.
The Senior Technical Manager - Pharmaceutical Sciences role will work within TOSI, On-market technical function of our Pharmaceutical Technology & Development (PT&D) organization. The PT&D Organization is responsible for drug product design, development and technical support for drug substances and products throughout the life cycle. TOSI is a multi-skilled, multi-platform, Global organization based in 13 locations in 7 countries and provides the expert technical support for AstraZeneca commercial small-molecule products.
This is an exciting opportunity to be part of a global organization and you will be responsible for the provision of strategic technical product leadership expertise to a portfolio of small-molecule commercial drug products requiring cross-brand solutioning to meet supply challenges. This will require you to apply existing experience in formulation design, dosage form manufacturing, technology transfer, and technical support to regulatory affairs.
What you'll do:
- Provide strategic commercial drug product leadership and technical expertise to enable cross-brand supply strategy, improve product performance and resolve technically challenging issues associated with drug product manufacturing.
- Influence decisions beyond PT&D and manufacturing sites to implement innovative standard solutions to technically challenging problems related to small-molecule drug product formulation and manufacturing.
- Enable technology transfer through oversight and governance as we create flexibility in AstraZeneca's Supply Chain.
- Lead the preparation and approval of technically complex responses to regulatory questions or regulatory updates as we maintain our License to Operate around the globe.
All these activities have a significant impact on the overall success of Operations by ensuring appropriate manufacturing and testing of AstraZeneca's commercial products. TOSI secures availability of AstraZeneca's products for the commercial organization and patients, impacting on both financial and reputational aspects of the business. Strong stakeholder management and leadership exposure is an important part of the role.Essential for the role:
- Bachelor's degree preferably in Pharmaceutical Sciences, Chemical Engineering or related field. Master's degree or PhD is preferred.
- Minimum of ten (10) years work experience in Pharmaceutical Operations and/or Pharmaceutical Research and Development.
- Ability to perform root cause analysis for problematic or variable manufacturing and analytical methods and identify and deliver improvement opportunities (e.g., using measurement systems analysis tools, design of experiments).
- Extensive experience of technology transfer activities, including required standards and experience in leading quality/technical risk management activities.
- Subject management expertise in OSD manufacturing processes such as granulation (wet/dry), sustained release dosage forms, compression, coating, etc.
- Understanding of Operations Manufacturing and principles, applications and management of cGMP and strong understanding of statistical principles.
- Strong leadership capabilities, including ability to influence globally and work in a team environment and strong communication skills.
- Working experience in Operations and or Product Development or other science areas (e.g., Formulation Sciences and Physical Sciences).
- Solid understanding in the application of Quality by Design and implementation of new technologies for pharmaceutical manufacture and testing.
- Understand process robustness, how to interpret cause and effect and implement control strategies.
- Training in, or awareness of, lean six sigma, including good understanding of statistical tools and experience of their application.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Interested? Come and join our journey!Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.Find out more on Social Media:
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