Senior Downstream Scientist, Manufacturing Production Support
2 days ago
Senior Downstream Scientist, Manufacturing Production Support
Apply locationsCopenhagen, Denmark
Time type: Full time
Posted on: Posted 2 Days Ago
Time left to apply: End Date: April 9, 2025 (18 days left to apply)
Job requisition id: JR101671
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.
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 Manufacturing Product Support department as a Downstream Scientist in one of our commercial teams. This position requires technical problem-solving, process understanding, and inter-departmental collaboration.
This includes supporting the production line with error-free and timely production execution, and owning batch documentation, review, and deviation handling. The team has in-depth knowledge of the product-specific requirements.
RESPONSIBILITIES:
- Accountable for creating the Master Production Record
- Responsible for reviewing the Master Production Record
- Responsible for support to the production
- On call/shopfloor scientist to ensure on-line support during critical process steps
- Responsible for facilitating solutions on how to proceed during breakdowns during batch execution
- Accountable for timely deviation closure (incl. systematic problem-solving during root cause investigation) as well as other quality documents
- Establish and maintain procedures to ensure compliance
Other:
- Customer meeting representative
- Audits and inspection support
- Responsible for capturing learnings and implementing continuous improvements to processes
- Knowledge about requirements for relevant products
EDUCATION AND EXPERIENCE:
The ideal candidate holds an Academic degree within Life Science and preferably has previously worked 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:
- Master's or Bachelor's Degree in natural or life science related fields
- 3 or more years of experience from a similar or related role
- Experience with downstream processes
- Preferably have experience writing, reviewing, and approving GMP documentation
- Preferably experience with operations of single-use technologies and aseptic processing
- Preferably experience in clinical/commercial GMP manufacturing
- Self-motivated, organized, and proactive
- Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Transfer, Process Validation, 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
You are someone who values diversity in both professional and personal spheres. Problem-solving is second nature to you, and you embrace new challenges with confidence, driven by personal dedication and determination. Even under pressure, you maintain a great sense of humor and excel in dynamic, ever-changing environments.
If you have questions about the above position, please reach out to Manufacturing Product Support Manager Nezrab Sedighi on +45 2610 8332 or nsedighi@agcbio.com. We treat applications as we receive them and conduct interviews with qualified candidates. Please submit your application as soon as possible. When the right candidate is found, the ad will close.
At AGC Biologics, you will get a unique opportunity to work 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 your 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.
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
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AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations, and ordinances.
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