Manufacturing Sciences & Technology- On Market Technical Leader - Statistician - Mount Vernon, IN | Biospace
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Manufacturing Sciences & Technology- On Market Technical Leader - Statistician

AstraZeneca Pharmaceuticals LP

Mount Vernon, IN
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Mount Vernon,
United States
Job reference: R-011501

Posted date: Aug. 07, 2017

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 the On Market Technical Leader – Statistics in Mt. Vernon, IN you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

This role resides in the PT&D (Pharmaceutical Technology & Development) Function in the Operations SET area. The PT&D organization is a responsible for drug product design, development and technical support for drug substance and products throughout the life cycle. The On-Market Technical Functions within PT&D provide the expert technical support for AZ commercial products. The On-Market Technical function is a multi-skilled organization who provide technical support and expertise related to formulation, manufacture, data analytics, devices and testing. The key activities where support is provided is related to technical management of improvement projects, changes, investigations, regulatory responses, new submissions, product robustness, validation, risk and manufacturability. Under pinning the excellent technical support that drives robust product supply are processes & strategies targeting knowledge management, manufacturability, technical validation approaches, problem solving with alignment to 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.

The On Market Technical Leader in the statistician role has the following responsibilities:

• 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 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.

This position is considered a matrix manager responsible at a project level. The remit of the role covers all AstraZeneca countries.

Essential Requirements
• Strong statistics background with application to the commercial manufacturing environment.
• Likely to hold a Masters or PhD in statistics or similar discipline (with elements of statistics) with ~7+years of relevant pharmaceutical industry work experience) post master’s degree and have professional credibility within the business and industry.
• Expert user of at least one statistical package (Minitab, SAS, R)
• A working knowledge in applying a wide range of statistical analyses to a manufacturing environment.
• 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
• 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.
• Have strong leadership skills and behaviors with demonstration of being able to work across different functions.
Desirable Requirements

· Experience in support of regulatory interactions and responses.
· Strong statistics background with application to the pharmaceutical commercial manufacturing and testing environment.
· Have an excellent understanding of the overall drug product development and commercialization process from development, launch and through life cycle management.
· Has experience of continued process verification.
· Significant amount of commercial technical drug product statistical support experience expected.
· Experience in applying current statistical methods and ASTM standards.
· Have a thorough understanding of principles, applications and management of SHE and cGMP.
· Experience in pharmaceutical Operations and/or R&D with a track record of successful project leadership and delivery within a matrix organization.
· Evidence of excellent communication skills and build excellent relationships with customers.
· Experience in or exposure to multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies
· Deep expertise in Manufacturing process design and development, including understanding of first principles/modelling of processes.

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.


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