Review and Compliance Supporter, ​Maternity Leave Position (18 Months)

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 the right fit for you!

As a CDMO, AGC Biologics manufactures drugs for a variety of customers. Depending on the customer needs, this can involve drugs ranging from development to clinical and commercial production. Right now, you have the opportunity to join the Microbial department as a Review and Compliance Supporter in Microbial Production Coordination Team, covering a maternity leave for 18 months. This position requires high level process and compliance understanding as well as inter-departmental collaboration.

The Microbial Production Coordination Team owns the production process for all products. This includes supporting production with error-free and timely execution, owning batch documentation, reviewing, and handling deviations. The team has in-depth knowledge of product-specific requirements.

RESPONSIBILITIES:

• Daily review of documentation in production.
• Accountable for timely batch review according to KPIs.
• Accountable for timely deviation closure (including systematic problem-solving during root cause investigations) according to KPIs.
• Responsible for enabling timely batch release.
• Responsible for data feedback/status on release process.
• Responsible for capturing learnings and aligning with MPR template owner to continuously improve MPR template.
• Responsible for sharing knowledge across project groups.
  

EDUCATION AND EXPERIENCE:
The ideal candidate 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 following competencies/experiences:

• Experience pharmaceutical 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.
• 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.

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.
Location: Copenhagen Site