Scientist I or Scientist II - GTO BES Technical Specialist

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!



In Biologics Global Technical Operations (GTO), we work closely with AstraZeneca's manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline. We are currently searching for a Scientist I or Scientist II GTO BES technical specialists.



As a Scientist I or Scientist II, GTO BES Technical Specialist, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. You will be recognized internally and externally as an expert in your area and an in-demand problem solver for key technical challenges. You will act as the key point of contact with assigned CMO partners and work with CMO subject matter experts in manufacturing, technical and quality teams supporting AZ products. In this capacity, you will work multi-functionally to drive technical initiatives, investigations and lifecycle management aspects of biological drug products. This role is based in Södertälje, Sweden.



What you'll do:

* Serve as single point of contract between CMO partner MS&T and Manufacturing into AZ Global Tech Ops teams to resolve production issues, deviations and lifecycle management aspects by working with relevant manufacturing site(s), Quality/Regulatory, Engineering, Validation, and Development to implement solutions.
* Drive implementation of continuous improvements projects working with other Global Tech Ops teams to ensure robust, reliable, and compliant commercial manufacturing processes using risk-based processes.
* Partner with team members from Global Technical Operations (GTO), Biologics External Supply (BES), and Global Supplier Quality to lead productivity improvement projects, deviation investigations, process change implementation and continuous process monitoring.
* Support preparation of regulatory submissions, oversight during inspections and audits, and respond to questions from regulatory bodies as required.
* Apply technical knowledge and expertise to achieve project requirements in a timely fashion and to agreed quality standards



To succeed in this role, you will need to be self-motivated, innovative, have strong technical and communication skills, and a good understanding of biologics manufacturing, quality, and process development.



Essential for the role:

Degree in an engineering or scientific field with experience in biopharmaceutical manufacturing/development/process engineering:

- Scientist I : B.S with 5+ years, MS with 2+ years, or PhD

- Scientist II: BS with 10 years, MS with 6+ years; or 2+ years with PhD

* Drug Substance or Drug Product Commercial and Technology Transfer experience.
* Experience working with biological products (Biologics and/or Vaccine)
* Proven technical experience developing, transferring, and/or supporting biological products within a pharmaceutical environment a plus.
* A detailed understanding of the principles and concepts for drug substance or drug product technology development and lifecycle management.
* Project management, innovation skills, and good understanding of critical unit operations involved in drug substance or drug product manufacturing.
* Knowledge of relevant compliance systems (e.g. deviation investigation, change control initiation and implementation) as appropriate to own function.
* Experience in Microsoft Windows applications, Risk- and Change Management Tools and methodologies



Evidence of strong communication skills and of building good relationships with multi-functional team members and customers. Ability to travel 10% of the time; typically within supported region, but may include some global travel within US, Europe and Asia.



Why AstraZeneca

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.



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. Welcome with your application no later than September 15th, 2021.