Outsourcing Manager - Pharmaceutical Product Development

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 diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we are 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 support 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 the main technical contact for communication and lead continuous improvement of the partnership for efficient and robust delivery.
The role requires you to be forward-thinking and adept at balancing immediate operational needs with long-term strategic vision. Navigating 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 exercises.
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 practices for outsourcing.
Maintain the portfolio oversight of outsourced developments in EPDM.
Compile input and info to support in/out decision in portfolio meetings, including 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 the Pharmaceutical Industry.
Significant experience of clinical drug product development, especially of oral solid dosage forms.
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 mindset.
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 Principal Scientist - Outsourcing Manager!
Location: Macclesfield UK
Salary: Competitive + Excellent Benefits!
Start date: ASAP
Salary: Negotiable

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