Outsourcing Manager - Early Pharmaceutical Product Development and Manufacturing

Do you have an interest in the area of pharmaceutical technology and want to drive drug development projects forward? Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.

We are now looking to hire an Outsourcing Manager, to strengthen our Early Product Development and Manufacturing (EPDM) team. EPDM is part of Pharmaceutical Sciences where we are supporting all therapy areas in the early clinical development stages up to phase 2b. EPDM teams are located in Gothenburg, Sweden, and Macclesfield, UK.

Role's Impact:

This role plays a pivotal role in establishing partnerships with external contract development and manufacturing organisations (CDMOs) and developing and reviewing  the technical outsourcing strategy  and process within EPDM.

This position is essential to our company's success by encouraging innovation to accelerate delivery of AstraZeneca’s evolving pipeline through strategic partnerships.

What You’ll Do:

You will identify and lead technical evaluations of potential CDMOs for development and manufacturing of drug products for early phase clinical trials. Additionally, you will act as main technical contact for communication and lead continuous improvement of the partnership for an efficient and robust delivery.

The role requires you to be forward-thinking and adept at balancing immediate operational needs with long-term strategic vision. Navigate complex collaboration environments and influencing cross-functional teams within and outside Pharmaceutical Sciences will be crucial.

We are looking for an experienced pharmaceutical scientist that has a good understanding of clinical drug product development. In this role, you will work closely with a team of colleagues within EPDM and cross functional teams within AstraZeneca where you will be a key player in driving the outsourcing strategy for EPDM and build an optimum way of working in the externalization space.  As skill lead in pharmaceutical project teams, you will provide technical and scientific expertise and input to development strategies for outsourced drug product development.. You will be accountable for:

• Lead efforts to establish and evolve ways of working for outsourced projects within EPDM including leading lessons learned exercise
• Skill lead for outsourced development of oral solid dosage forms, including authoring of CMC regulatory submissions, optimally lead technology transfer and ensuring documentation to current standards including GMP, where appropriate
• Coach EPDM colleagues in ways of working and best practice for outsourcing
• Maintain the portfolio oversight of outsourced developments in EPDM
• Compile input and info to support in/out decision in portfolio meetings incl recommendations of CDMOs to be used
• Participate in scientific and/or technology networks to increase knowledge and build awareness of new developments in relevant areas
• Contribute to implementation of new technologies for development and manufacturing of oral solid dosage forms through external partners

Essential for the role

• MSc or PhD in a field relevant to formulation science, analytical science, or pharmaceutical technology, and with extensive experience in drug product development in Pharmaceutical Industry
• Significant experience of clinical drug product development, especially of oral solid dosage forms
• Having a knowledge of operational requirements including GMP and SHE
• Delivery focused and a rational approach to problem solving, and an ability to make judgements based on sound reasoning
• A great teammate with the ability to collaborate with experts in complementary areas in a multicultural environment
• Operates confidently and collaboratively within a global organization, with an integrating mind-set
• Strong communication skills in English and stakeholder management skills

Are you ready to push the boundaries of science and make a real difference? Apply now to join our team as an Associate Principle Scientist – Outsourcing Manager!

Location: Macclesfield UK

Salary: Competitive + Excellent Benefits!

Where can I find out more?

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When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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.