Technical Manager, Statistics (Pharma) - Operations
AtAstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
This role resides in the manufacturing science and technical (MS&T) function within the PT&D (Pharmaceutical Technology & Development) Organization in the Operations SET area. The PT&D Organization is responsible for drug product design, development and technical support for drug substance and products throughout the life cycle.
The MS&T Function provide the expert technical support for AstraZeneca commercial products. It is a multi-skilled organization who provide technical support and expertise related to drug product formulation, manufacture, process engineering, statistics, modelling, devices and testing. The key activities where we deploy our technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk and manufacturability.
Under pinning 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 organization and our ways of working.
This role specifically resides in a global group, Product Robustness CoE. The Product Robustness CoE provides support for data analytics (statistics and chemometrics), knowledge management, product robustness framework ownership for Operations and lifecycle of validation. We are responsible for ensuring that there is a process, standards, tools and skills for the delivery of robust products and processes. Within that we have identified that expert statistical skills are critical to the delivery of robust processes, methods and products. This position is part of a team that plays a key role in ensuring security of supply to patients.
- Responsible expert for the delivery of technical standards and guidance for statistical approaches required to ensure commercial drug product quality and robustness.
- Provision of statistical expertise to aid in the resolution of manufacturing/method/formulation issues & complaints impacting supply or manufacturability.
- Provision of statistical support in the event of product recall incidents
- Development of suitable statistical approaches in support of corrective and preventive actions for investigations in conjunction with product experts.
- Provision of statistical expertise to support product supply strategy projects (sourcing, asset transfers, capacity expansion etc) and business continuity plans through delivery of the drug product control, manufacturability strategy and product quality risk management activities throughout the lifecycle.
- Responsible for the statistical support during the transfer of established products within sites and to external manufacturing partners including support (both design and analysis) for equivalency determination as applicable.
- Support for drug product PPQ programs & sampling plan development in the support of transfer and change activities.
- Management of product knowledge in relation to statistics throughout the lifecycle.
- Supports global review of product performance via appropriate dash-boards/CPV assessments to ensure product and process robustness.
- Maintain technical knowledge in area of subject matter expertise including up to date advances in new technologies or tools to aid in the improvement of pharmaceutical processes and or methods relevant to statistics and data analysis.
- Provide support for regulatory file authoring, review, license renewals and response to questions.
- Support for defining technical standards impacting commercial products specific to regulatory expectations and good business or quality standards (including pharmacopeial standards).
- Provision of training in subject matter expertise areas.
- Determination of drug product shelf life periods through trending of stability data
- Maintain competency in the use of statistical tools & software applications relevant to support of on market technical support areas for example including but not limited to: Design of Experiments, equivalency, trend analysis, stability analysis and release limit setting, measurement system analysis.
- Masters or PhD in statistics or similar discipline with elements of statistics with
- 7+ years of relevant pharmaceutical industry experience, post MS degree
- 4+ years of experience post PhD degree and have professional credibility within the business and industry.
- Strong statistics background with application in a commercial manufacturing or testing environment.
- Has experience of process monitoring or continued process verification.
- Experience in support of regulatory interactions and responses.
- Experience in applying current statistical methods and ASTM standards.
- Track record of successful project leadership and delivery within a matrix organization.
- Evidence of excellent communication skills and relationship building with customers.
- Expert user of at least one statistical package (Minitab, SAS, R)
- Experience in applying the concepts for at least some of the following areas: Statistical Quality Control, linear modelling, experimental Design, sampling Plans, exploratory Data Analysis, Mixed Effect Models
- Have an excellent understanding of the overall drug product development and commercialization process from development, launch and through life cycle management.
- A working knowledge in applying a wide range of statistical analyses to a pharmaceutical manufacturing and/or R&D environment
- Have a thorough understanding of principles, applications and management of SHE and cGMP.
- Deep expertise in Manufacturing process design and development, including understanding of first principles/modelling of processes.
- Ability to perform root cause analysis for problematic or variable products and identify and deliver improvement opportunities (using formal tools and processes)
- Have previous experience and training in Lean and six sigma, problem solving tools.
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.