Job Description

Are you an experienced scientist looking for a role where your expertise can make an outstanding impact? Can you envision joining a dynamic and enthusiastic environment, delivering critical support to commercial products and market access projects? Then join us in this exciting opportunity!

AstraZeneca is a global, innovative BioPharmaceutical business that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world\xe2\x80\x99s most serious disease. At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

We have an exciting opportunity to join as a Senior Scientist - Analytical Sciences in the Analytical Science & Technology CoE! In this role you will work within Technical Operations, Science and Innovation (TOSI), a key function of our Pharmaceutical Technology & Development (PT&D) organization.

The PT&D Organization is responsible for drug product design, development and technical support for drug substance and products throughout the lifecycle. TOSI is a multi-skilled global organization based in 13 locations in 7 countries, which provide technical leadership and subject matter expert support to AstraZeneca commercial small molecule drug products. Our technical support and expertise spans from formulation, process engineering, analytical, and statistics to devices, packaging and manufacturing technology strategy. The areas in which we deploy our technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, product launches and regulatory submissions, product robustness, validation and risk evaluation.

What you\xe2\x80\x99ll do

As Senior Scientist - Analytical Sciences, you will be responsible to provide analytical subject matter expert (SME) support to drug products (small molecules) from their introduction at manufacturing sites and across their commercial lifecycle. Using your knowledge in analytical science and analytical technologies, you will provide expertise to ensure efficient and effective support to internal and external manufacturing sites and testing laboratories located in multiple countries. In this role, you may be the product analytical lead for drug products, coordinating TOSI activities and being the main point of contact for our customers, as well as representing TOSI in the Global Supply Teams (GST) and/or Pharmaceutical Teams (PT)

Your main accountabilities will include:

• Being a key analytical contact, or accountable lead for drug products and supporting all analytical lifecycle activities to ensure testing methods, specifications and control strategies are and remain fit for purpose and aligned with technology advancements.
• Working as SME in multi-functional cross-site teams supporting analytical technology transfer projects to internal and external manufacturing and testing sites.
• Leading and assessing technical changes and playing a proactive role in identifying opportunities for analytical method improvements, including automation.
• Providing analytical subject matter expertise in support of issues investigations in QC laboratories and manufacturing sites.
• Performing laboratory work, when needed by projects and products.
• Providing SME support during the regulatory file authoring and the interaction with local authorities for regulatory submissions, variations, and license renewals.
• Supporting analytical risk assessments related to nitrosamines, extractables & leachables, elemental and organic impurities.
• Providing technical support to Issue Management Teams (IMT).
• Supporting the definition of analytical standards impacting commercial products, specific to regulatory expectations and good business, or quality standards (including pharmacopeial standards).

Essential requirements

• MSc or PhD degree, complemented with considerable experience in an appropriate subject area such as Chemistry, Pharmacy, Pharmaceutical Sciences or similar.
• Strong technical knowledge, great interpersonal skills and proven track record to lead and collaborate across teams, functions and locations.
• A good understanding of the overall drug development and commercialization process from development, launch and through life cycle management
• In-depth understanding of analytical sciences in the Pharmaceutical Industry, applied to raw materials, intermediates and drug products, including definition of control strategies and specification setting, analytical methods validation, transfer and optimization and proven knowledge of a broad range of analytical techniques.

• Experience of 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 thorough understanding of principles, applications and management of SHE and cGMP.

Desired for the role

• Experience in or exposure to multiple subject areas in CMC and related functions (e.g. product development, on-market support, manufacturing and testing)
• Previous experience and training in Lean, problem solving tools and experience in data analysis and interpretation

Why AstraZeneca

Join our global team to experience our inclusive and encouraging culture. We believe in shared success, a place where ideas are welcomed and awarded. Be comfortable speaking up, taking responsibility for your actions and working together to succeed. This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.

Date Posted 19-Jul-2023

Closing Date 12-Aug-2023

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 authorization and employment eligibility verification requirements.

AstraZeneca