Technical Manager - Analytical Chemistry
Technical Manager - Analytical Chemistry
12 Month Secondment/Fixed Term Opportunity/Fixed Term Contract
AstraZeneca is a global, innovation-driven bio-pharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energised and rewarded for their ideas and creativity.
The PT&D (Pharmaceutical Technology & Development)Organization is responsible for drug product design, development and technical support for drug substance and products throughout the life cycle. MS&T (Manufacturing Science and Technology)is a multi-skilled organisation based in 7 locations in 5 countries and provide the experienced technical support for AstraZeneca commercial oral solid dosage products.
MS&T provide technical support and expertise related to product formulation, manufacture, process engineering, statistics, modelling, devices and testing. Underpinning the excellent technical support that drives robust product supply are technical processes & strategies around knowledge management, manufacturability, technical validation approaches, problem solving in alignment with the delivery of the technical inputs needed for fulfilling the Global Product Supply Strategy. The On-market technical functions are a strong network of scientists located across the world at our key manufacturing, development sites and strategic hubs. We work closely with many technical functions across Operations providing the ability to drive science and build capability within our organisation and our ways of working.
- Responsible specialist for a major commercial product or group of products related to the Analytical Methods subject matter area
- Provision of technical expertise & leadership to aid in the resolution of analytical method issues & complaints impacting supply
- Development of corrective and preventive actions in support of investigations
- Responsible for the technical support during the transfer of established product analytical methods within sites and to external manufacturing partners including support for equivalency determination
- Lead, assess impact & support technical improvements or change activities assuring product and methods performance
- Responsible for analytical method lifecycle activities to ensure performance and compliance across sites
- Find opportunities for analytical method improvements
- Provide support for regulatory file authoring, review, license renewals and response to questions
- Provision of training in domain expertise areas
Required Skills & Knowledge
- Master degree or PhD level with considerable experience post degree in an appropriate subject area such as Chemistry, Pharmacy, Pharmaceutical Sciences or similar discipline
- An excellent understanding of OSD products life-cycle, from launch and through life cycle management until discontinuation
- An understanding of commercial product requirements in the areas of analytical methods establishment and optimisation, control of drug products, biopharmaceutics, stability, trace analysis (e.g. elemental impurities, extractables & leachables)
- An understanding of a broad range of Analytical techniques (standard and non-standard)
- Significant experience in analytical methods optimization and transfer, including understanding of equipment and method capability and performance
- Significant experience in issue investigation and change assessment from analytical point of view. Good knowledge of standard tools for root cause analysis (5 whys, PPS, Level 0, etc…)
- A detailed understanding of principles, applications and management of SHE and cGMP
- Experience in Operations and/or R&D with a track record of successful project delivery
- Evidence of excellent communication skills and build excellent relationships with customers
Preferred Skills & Knowledge
- Experience in, or exposure to, multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
- Previous experience and training in Lean, problem solving tools and have experience in data analysis and interpretation
- Strong leadership skills and behaviours with demonstration of being able to work across different functions
The site provides a collaborative environment where everyone feels comfortable and able to be themselves which is at the core of AstraZeneca’s priorities
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.