Product Technical Lead (Technical Manager, Pharmaceutical Sciences) – Mt Vernon - Global Operations
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Product Technical Lead (Technical Manager, Pharmaceutical Sciences)in Evansville / Mount Vernon, IN, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.
AstraZeneca is at a critical phase in the journey to deliver our bold ambition; to improve the lives of 200 million patients and be a $50 billion company in 2025. We are on track to deliver 10 new medicines by 2020, and we have one of the most exciting portfolios in the industry.
Pharmaceutical Technology and Development (PT&D) is the bridge that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices for new medicines and providing expert technical support to all AZ’s commercial drug substances and products to ensure we successfully supply medicines to patients.
We’re currently looking for a talented Product Technical Lead (Technical Manager, Pharmaceutical Sciences) to play a key role in our Manufacturing Sciences and Technology (MS&T) group. You will be responsible for the provision of technical product leadership expertise to a portfolio of oral solid dose (OSD) commercial products.
Your responsibilities will include:
- Provide commercial drug product leadership technical expertise to aid the resolution of incidents with potential market impact and complex analytical method related issues
- Provide technical assessments for proposed product and supply chain changes, highlight technical risks, and recommend work packages needed to support the change(s)
- Identify and deliver product and process improvement initiatives for established products
- Support creation and delivery of Manufacturability Strategies
- Contribute to the preparation and approval of technically complex responses to regulatory questions
- Be responsible for technical oversight and governance during the technology transfer of established products
- Influence decisions at manufacturing sites and at suppliers (e.g., in respect to manufacturing equipment capital investments
- Manage product technical knowledge for a portfolio of products
- Project manage strategic initiatives, including securing sponsorship, resource requirements, stakeholder management, timing and benefits tracking
- Identify opportunities to develop technical capabilities within Operations sites, and provide training to meet agreed capability targets
- Assess the technical capabilities of potential new external manufacturing partners and make supplier selection recommendations
- This position has no direct reports.
All these activities have a significant impact on the overall success of Operations by ensuring appropriate manufacturing and testing of AstraZeneca’s commercial products. MS&T secures availability of AZ’s products for the commercial organization and patients, impacting on both financial and reputational aspects of the business.
- Educated to BSc or PhD level preferably in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering or related discipline. Plus 7+ years post degree work experience in Pharmaceutical Operations and/or Pharmaceutical Research & Development and a track record of successful delivery within a matrix organization.
- Detailed understanding of the overall drug development and commercialization process from development, launch and through life-cycle management
- Strong analytical & scientific thinking background (e.g., Pharmaceutics and Process development and optimization understanding)
- Ability to perform root cause analysis for problematic or variable 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 best practices
- Experience in leading quality/technical risk management activities (e.g., QRAs)
- Experience in OSD manufacturing processes such as granulation (wet/dry), sustained release dosage forms, compression, coating, etc
- Understanding of Operations Manufacturing
- Understanding of principles, applications and management of cGMP
- Strong understanding of statistical principles
- Strong leadership capabilities, including ability to influence globally and work in a team environment
- Strong communication skills
- Working experience in Operations and or Product Development
- Working experience in other science areas (e.g., Formulation Sciences and Physical Sciences)
- Working knowledge 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
- Expert in OSD manufacturing processes such as granulation (wet/dry), sustained release dosage forms, compression, coating, etc.
- Training in, or awareness of, lean six sigma, including good understanding of statistical tools and experience of their application
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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.