Demo

Principal Scientist, Quality Assurance

AGC Biologics A/S
Copenhagen, NY Full Time
POSTED ON 4/3/2025
AVAILABLE BEFORE 6/3/2025

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.

QA for Material Management:
QA for Material Management is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, many with several years of experience within quality assurance.

This QA team is responsible for support of Supply Chain Management and QC in the areas for deviations, CAPA, change management, complaints, GMP documentation etc. in relation to material management. We also have oversight of the respective areas and assist with internal and external audits and regulatory inspections.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that QC and manufacturing are in compliance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.

The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA Operations department is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

Role & Responsibilities:

As QA Principal Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment. Your main responsibility will be to support Supply chain, Process Transfer and QC for late stage and commercial products, which includes:

  • Close collaboration with internal stakeholders
  • Change control, deviation handling and CAPAs
  • Review and approval of material specifications
  • Release of raw materials and disposables

We cooperate closely with the other departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP.

Your Profile:

The ideal candidate has 3 years of experience with Quality Assurance and/or material management. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology, chemistry or similar. Additionally, you have experience within the following areas:
 

  • Proven experience from QA and/or Material Management
  • Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates, APIs and Cell Banks
  • QA oversight and guidance of staff
  • Experience with contract manufacturing and business understanding
  • Deviation handling including root cause investigations
  • Review and evaluation of cGMP documentation

It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience.

Your Application:

Apply today! We will process the applications as they arrive. The job ad will close once we have found the right candidate.

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.

If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

What is the career path for a Principal Scientist, Quality Assurance?

Sign up to receive alerts about other jobs on the Principal Scientist, Quality Assurance career path by checking the boxes next to the positions that interest you.
Income Estimation: 
$63,136 - $79,042
Income Estimation: 
$78,244 - $97,353
Income Estimation: 
$130,030 - $173,363
Income Estimation: 
$194,895 - $259,743
Income Estimation: 
$192,057 - $260,440
Income Estimation: 
$249,515 - $311,938
Income Estimation: 
$155,477 - $213,492
Income Estimation: 
$124,827 - $154,865
Income Estimation: 
$155,149 - $198,874
Income Estimation: 
$68,606 - $89,684
Income Estimation: 
$88,975 - $120,741
Income Estimation: 
$68,121 - $81,836
Income Estimation: 
$71,928 - $87,026
Income Estimation: 
$125,958 - $157,570
Income Estimation: 
$63,136 - $79,042
Income Estimation: 
$78,244 - $97,353
View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

Job openings at AGC Biologics A/S

AGC Biologics A/S
Hired Organization Address Copenhagen, NY Part Time
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healt...
AGC Biologics A/S
Hired Organization Address Copenhagen, NY Part Time
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healt...
AGC Biologics A/S
Hired Organization Address Copenhagen, NY Full Time
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healt...
AGC Biologics A/S
Hired Organization Address Copenhagen, NY Full Time
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healt...

Not the job you're looking for? Here are some other Principal Scientist, Quality Assurance jobs in the Copenhagen, NY area that may be a better fit.

Principal Scientist, Quality Assurance Microbial

AGC Biologics A/S, Copenhagen, NY

Regional Operations Director USA

Quality Assurance Company, Maryland, NY

AI Assistant is available now!

Feel free to start your new journey!