- B.S., M.S., or Ph.D. in Biotechnology, Pharmacy, Mechanical Engineering, or other relevant Engineering field, Pharmaceutical Sciences, or related field with experience in the biopharmaceutical industry
- Expertise in drug product/combination product process development and characterization
- Strong knowledge of Quality Risk Management principles and tools
- Experience in CMC aspects of biopharmaceutical development
- Demonstrated ability to work in a collaborative team environment across multiple technical functions
- Strong aseptic processing knowledge (Annex 1 and similar)
- Process validation execution
- Ability to work independently with minimal direct oversight
- Ability to manage up and influence senior partners
- Experience with tech transfer
- Non-conformance investigation and root cause analysis
- Corrective/Preventive action implementation
- Experience with regulatory agency interactions or responses to regulatory queries specific to pharmaceutical development and medical devices
- Strong statistical background, including SPC and DoE methodologies
- Knowledge of Six Sigma
- Knowledge of combination product and/or medical device development and associated design controls
- Experience with various biologic modalities (mRNA, adenovirus delivery, CAR-T therapies, antibody-drug conjugates, etc.)
- Experience with formulation development
- Experience with lyophilization development, characterization, and scale-up
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Senior Engineer, Drug Product Process Engineering - Södertälje, Sverige - AstraZeneca
Beskrivning
At AstraZeneca, we put patients first and strive to meet their unmet needs 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.
AstraZeneca's BioPharmaceutical Development (BPD) department consists of scientists, engineers, mathematicians and project managers whose ambition is to transform biologic molecules into life-changing medicines.
The Process Engineering and Packaging Group (PEP) Group sits in the BioPharmaceutical R&D organization. The PEP group develops clinical and commercial fill/finish processes, combination product assembly processes, and packaging for biopharmaceutical products in the AstraZeneca portfolio. This role will be based at Sweden Bio-manufacturing Center (SBC), and will serve to strengthen collaboration between development and the manufacturing operations business units. SBC, our new production unit in Södertälje, is a central part of AstraZeneca's strategy for the production, quality assurance and delivery of biological medicines.
Your role
We are currently seeking a highly skilled individual for Senior Engineer role, with one focused on CP Combination Assembly Design Transfer and the other on Drug Product Aseptic Fill/Finish Technology Transfer. As a key member of the PEP organization, you will play a crucial role in process development for late-stage clinical products, technology transfer to both internal and outsourced commercial manufacturing.
In this role, you will provide technical and strategic leadership for the development of drug product processes and parenteral device assembly processes for late-stage programs. You will apply scientific and engineering knowledge to solve issues arising during development and execution of processes. Additionally, you will lead technology development initiatives, drive a culture of innovation, and create solid partnerships with key interfaces.
Our site in Södertälje is where you'll collaborate with AstraZeneca leaders, particularly within the Global Biological Operations (Commercial Operations) organization, as well as internal/external manufacturing sites within our network. Your experience working with functions such as late-stage formulation development, device development, clinical operations, supply chain, quality, and regulatory will be essential for success in this role.
Essentials
When we put unexpected teams in the same room, we fuel 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.
Desirables
Why AstraZeneca
Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It's inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people's lives better – from patients and their families to all of us in society.
So, what's next
Welcome with your application no later than 5th May 2024.
Date Posted
25-apr.-2024Closing Date
05-maj-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
