Review & Documentation Scientist

at  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.
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 review and documentation Scientist in one of our commercial teams. This position requires high level process and compliance understanding as well as inter-departmental collaboration.
The team owns the production process of some of the products produced in AGC Biologics. This includes to support the value streams 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.

EDUCATION AND EXPERIENCE:

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:

• Master’s Degree in Engineering or Protein Science-related field or similar
• Have experience writing, reviewing and approving GMP documentation.
• Experience preferably in clinical/commercial GMP manufacturing.
• Have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
• 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.

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.
For further information regarding the position, please contact Manufacturing Product Support Manager Nezrab Sedighi at +45 2610 8332. We treat the applications as we receive them and conduct interviews with qualified candidates. Please submit your application as soon as possible. When the right candidate are found, the add will close.
At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +50 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.
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
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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

Prior to batch execution

• Responsible for/consulted during MPR creation on process steps to align production flow and GDocP requirements

After batch execution

• 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