Technical Lead/ GMP Facility Manager

At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

Pharmaceutical Sciences is accountable for the design and development of synthetic routes, preclinical and phase I/II formulations, encompassing both small molecules and new modalities such as mRNA and oligonucleotides, across the whole range of AstraZeneca's therapeutic areas.

Within Early Product Development and Manufacture (EPDM) in Gothenburg, Sweden, the manufacturing unit is accountable for delivering a vast portfolio of early investigational medicinal products. We have a wide range of manufacturing assets in three separate manufacturing facilities, supplying different types of clinical trial material to studies across the globe.

We are now looking for a skilled Technical Lead/ GMP Facility Manager to join us at EPDM. The role will be located at our R&D site in Gothenburg, Sweden. The level of the role will depend on candidate's previous experience.

Within the EPDM manufacturing unit, in the GMP (Good Manufacturing Practice) arena, you will act in a technically advanced role. We see that the role holder has strong engineering competence, credibility, and ability to lead and give assured direction in capital projects as well as operative units in every day work related to Facilities (Clean rooms, HVAC, Clean utilities, Clean in Place) and integrated Equipment, all with GMP validated status.



What you'll do

A major focus will be to monitor and develop the condition and usage of assets, as well as assuring right capability and quality to enable GMP manufacture and pharmaceutical project development. You will be a key player in Tactical and Operational Governance/Facility forums, bringing together and collaborating with internal and external partners to ensure compliance and continuous improvement of capacity and capability. You will be main point of contact to set right quality standards within the framework of GMP, Safety, Health and Environmental sustainability. Listed activities below will have a significant impact on the speed, quality, and cost of the AZ development portfolio.

We expect the successful candidate to:

* Provide strong technical competence, guidance and willing to learn further, to assure facilities are validated, monitored (Environmental Monitoring System), serviced and calibrated according to agreed schedules. Be the main point of contact as Subject Matter Expert for troubleshooting, investigations and technical knowledge in e.g., deviation and change management, as well as development and maintenance of SOPs and training material.
* Provide solid contribution in project delivery and validation competence in facility refurbishment and installation of new equipment/ technology.
* Have excellent collaboration skills, working closely with internal and external partners to ensure compliance within the framework of GMP and Safety, Health and Environment. Have an interest to be part of continuous improvement of capabilities, improving our capacity and agility in manufacture.
* Coordinate/Lead activities associated with any changes such as refurbishment and installation of new equipment within the facility.
* Participate in the preparation of inspection documentation and give explanations concerning the processes and facility for regulatory inspections at the Gothenburg site.
* Be entrepreneurial and drive initiatives to further improve flexibility and productivity, bringing in and qualify new assets, resulting in shorter lead times or increased value for our customers and patients.

Experience/requirements

* MSc in chemistry/pharmacy/engineering or equivalent experience.
* Proven high technical knowledge and project leadership skills and ability to operate both independently and in good collaboration in a culturally diverse, complex, and changing environment.
* Good understanding of development within the industry and the impact on the organisation.
* Knowledge of cGMP and appreciation of Lean principles, applications and management of Engineering, Automation, Computerized systems and current Quality Management standards.
* Excellent documentation skills both in English and Swedish.
* Interest and understanding in manufacturing equipment and automated systems are a benefit.
* Experience from commissioning/qualification/validation of pharmaceutical processes and facilities or working in manufacturing/clean room or supply chain organisation and knowledge of cGMP is a merit for this role.

Why AstraZeneca

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. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next? Are you already imagining yourself joining us? Good, because we can't wait to hear from you! Welcome with your application (CV and cover letter) no later than December 12th 2023.

We will review the applications continuously so please apply as soon as possible.