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 - Analytical Sciences in Mt, Vernon, IN, 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 to ensure we successfully supply medicines to patients.
As the Technical Manager - Analytical Sciences, you will play a key role in our Manufacturing Sciences and Technology (MS&T) group. You will be responsible for the provision of analytical sciences expertise to a portfolio of oral solid dose (OSD) commercial products.
• Provide analytical 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 analytical methods 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 analytical technology transfer of established products.
• Influence decisions at manufacturing sites and at suppliers, e.g. in respect to Quality Control 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.
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 organisation and patients, impacting on both financial and reputational aspects of the business.
• Educated to BSc or PhD level preferably in Chemistry or related discipline. Plus 10 -15 years 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 commercialisation process from development, launch and through life-cycle management.
• Strong analytical testing background, e.g. method development, validation and routine use of specification, in-process control and/or PAT methods.
• 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.
• Extensive experience of analytical technology transfer activities, including required standards and best practices.
• Experience in leading quality/technical risk management activities, e.g. QRAs.
• Understanding of Operations Quality Control laboratories.
• 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 Quality Control laboratories.
• Working experience in other science areas, e.g. Chemical Sciences, Formulation Sciences and Physical Sciences.
• Working knowledge in the application of Quality by Design and implementation of new technologies for pharmaceutical manufacture and testing.
• Training in, or awareness of, lean six sigma, including good understanding of statistical tools and experience of their application.
• Experience in implementation of new analytical technologies for example: Raman, automated methods.
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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca