Senior Scientist, Manufacturing

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.

Downstream Senior Scientist – Manufacturing Product Support

At AGC Biologics, our work doesn’t stop at producing medicines - we ensure they are delivered consistently, safely, and at the highest quality for patients worldwide.

As a Downstream Senior Scientist in our Manufacturing Product Support team, you will play a critical role in keeping commercial production running smoothly. You will be the link between process understanding and real-time execution - supporting the shop floor, solving complex challenges, and ensuring that every batch meets GMP standards.

If you are motivated by technical problem-solving, cross-functional collaboration, and making an impact in a live production environment, this is an opportunity to grow your expertise while contributing to something meaningful.

The team owns the production process of all buffers and media for production. This includes to support the production line 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.  

  
Responsibilities

• Accountable for creating the Master Production Record 
• Responsible for reviewing Master Production Record  
• Responsible for support to the production 
• On call/shopfloor scientist to ensure on the line support during critical process steps 
• Responsible for facilitating solutions on how to proceed during break-down 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 implement cont. improvements to process. 
• Knowledge about requirement for relevant products. 

What will help you succeed

The ideal candidate holds an Academic degree within Life science and has 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:  

• Masters or Bachelors Degree in natural or life science related fields 
• Minimum 5 years experience  
• 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.  

A global environment where you can grow and make an impact

AGC Biologics is a global CDMO supporting biotech and pharmaceutical companies in bringing new biologic medicines to patients worldwide.

In this role, you will work with state-of-the-art technologies alongside colleagues from more than 40 nationalities. You will gain exposure to a wide range of products and processes, creating strong opportunities for both professional growth and personal development.

We believe that a positive and collaborative environment drives the best results. That is why we foster a culture where people support each other, take ownership, and enjoy working together as one team.

Take the next step in your career

If you are looking for a role where you can combine scientific expertise, real-time problem solving, and cross-functional collaboration - while contributing to the production of life-changing therapies - we would like to hear from you.

Apply through our recruitment system and become part of a team where your work truly makes a difference.

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.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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.