Job reference: R-011358
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 Technical Manager, Pharmaceutical Sciences you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
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 toensure we successfully supply medicines to patients.
We’re currently looking for a talented 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.
• 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.
Additional Desirable Requirements
• 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.