Scientist, QA Mammalian

AGC Biologics A/S; København; On-site; DKK 550,000 - 750,000; Full time

Job summary

AGC Biologics in Søborg, Denmark, seeks a QA Scientist to join the Mammalian team to support quality assurance across manufacturing and batch release of biotechnological products.

You will act as the primary QA partner for manufacturing operations, ensuring GMP compliance and timely disposition of batches throughout the production lifecycle.

Qualifications

• Master’s degree and at least two years in Quality Assurance.
• GMP background with a minimum of five years of relevant experience.
• Experience in biopharma or a CDMO environment is highly advantageous.
• Fluent written and spoken English with strong communication skills.

Responsibilities

• Batch review and release activities for manufacturing operations.
• QA review and approval of GxP documents (Change controls, Deviations, CAPAs, DS specifications, MPRs, Risk Assessments).
• Support generation and improvement of SOPs for the department.
• Take on QA responsibilities for projects and participate in client audits when needed.
• Provide on‑call duty support; shift every month.

Skills

Quality Assurance

GMP

Documentation

Communication (English)

Biopharma/CDMO experience

Education

Master’s degree

Job description

Are you curious about Mammalian manufacturing processes in a global CDMO environment? Do you have a strong GMP background from the pharmaceutical industry, preferably from QA. We are looking for a new colleague to join our QA Mammalian team in Søborg! Make a difference in Quality Assurance! The QA Mammalian team is looking for a QA Scientist to assist with QA of biotechnological production. The main responsibility of QA Mammalian is to ensure quality assurance of manufacturing activities and batch release of mammalian recombinant manufacturing of drug substances (DS) and Cell banks. The QA team consists of scientists and senior scientists. The department has an open communication with a focus on a high level of professionalism. We are open-minded and have a high service level for our colleagues in the rest of the AGC Biologics organization - and not least for our international customers. The QA Mammalian team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration. We actively work within our field of understanding and interpreting legislation to ensure manufacturing follows current standards for GMP production, i.e., EU GMP, 21CFR and ICH guidelines. Continuously, we improve our standards within quality and manufacturing processes, innovate with modern technology and our common value chain with internal stakeholders.

You will have an impact on the quality of the products! You will act as the primary QA partner for manufacturing operations, providing quality oversight, supporting timely batch disposition, and ensuring GMP compliance throughout the production lifecycle.

Key Responsibilities

• Batch review and release activities
• QA review and approval of GxP documents, including but not limited to: Change controls, Deviations, CAPAs, DS specifications, Master Production Records, Risk Assessments
• Supporting the generation of new, as well as improvement of, existing department SOPs
• QA responsibilities for projects
• Supporting client audits when necessary
• Providing on‑call duty support; shift every month

You must have an ability to work in a fast paced, matrix environment where prioritizing multiple tasks is key to meeting deadlines. 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.

Qualifications

• Relevant Master’s degree and at least two years of experience in Quality Assurance
• Broader GMP background with a minimum of five years of relevant experience
• Experience in biopharma or a CDMO environment is highly advantageous
• Hands‑on experience supporting GMP manufacturing operations and batch disposition activities within a drug substance, drug product or CDMO environment
• Communication in both written and spoken English is fluent
• Excellent written and verbal communication skills to internal and external stakeholders

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial‑based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. AGC Biologics is Your Friendly CDMO Expert – dedicated partners with the expertise and commitment to support our customers and teams. We work with some of the world’s most innovative pharmaceutical companies to develop and manufacture their life‑changing drug products.