Scientist, Manufacturing
7 days ago
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 customers. Depending on 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 Scientist in one of our Commercial, Microbial teams. This position requires technical problem-solving, process understanding, and inter-departmental collaboration.
The team owns the production process of all buffers and media for production. This includes supporting the production line with error-free and timely 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 Master Production Record.
- Responsible for support to the production.
- On-call/shop floor scientist to ensure on-the-line support during critical process steps.
- Responsible for facilitating solutions on how to proceed during breakdowns during batch execution.
- Accountable for timely deviation closure (including 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 sciences and 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:
- Masters or Bachelors Degree in natural or life science related fields.
- Knowledge of upstream or/and 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.
At AGC Biologics, you will get a unique opportunity working with a variety of 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.
Location: Copenhagen Site
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