Scientist, Manufacturing
Employer: AGC Biologics
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, customers and own development. AGC offers an informal and friendly working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team.
Location: Copenhagen, Denmark
The Role & Department
Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth? Then this position could be something for you.
As a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be for drugs ranging from development, to clinical and commercial production. Right now, you have the opportunity to join the Mammalian department as a Review and compliance Supporter in Mammalian Production Coordination Team. This position requires high level process and compliance understanding as well as inter-departmental collaboration.
The Mammalian Production coordination team owns the production process of all products. This includes to support the Production with an error-free and timely production execution and own batch documentation, review and deviation handling. The team has in depth knowledge of the product specific requirements.
Responsabilities
- Responsible for/Consulted during MPR creation on process steps to align production flow and GDocP requirements.
- Daily review of documentation in production.
- Accountable for timely batch review according to KPI.
- Accountable for timely deviation closure (incl. systematic problem-solving during root cause investigation) according to KPI.
- Responsible for enabling timely batch release.
- Responsible for data feedback/status on release process.
Other
- Responsible for capturing learnings and align with MPR template owner to continuously improve MPR template.
- Responsible for sharing knowledge across project groups.
Requirements
The ideal candidate holds an Academic degree within science and have previously been working in a manufacturing team operating under cGMP preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences:
- Experience in preferably in commercial/commercial GMP manufacturing.
- Have experience with and demonstrated understanding of Good Manufacturing Practices (GMP).
- Have experience writing, reviewing and approving GMP documentation.
- Experienced with operations of single-use technologies and aseptic processing.
- Self-motivated, organized and proactive.
- Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Transfer, Process Development, Engineering, QA, QC, etc.).
- Experience working with multiple projects simultaneously.
- Demonstrated experience leading troubleshooting efforts.
- Strong communication skills necessary to interact with internal and external stakeholders.
- Strong presentation skills.
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