Scientist, QA Mammalian

AGC Biologics; København; On-site; DKK 520,000 - 680,000; Full time

Job summary

AGC Biologics is seeking a QA Scientist to support GMP-compliant manufacturing and batch release within the QA Mammalian team. The role emphasizes quality oversight and timely disposition of batches, ensuring compliance with EU GMP, 21 CFR and ICH guidelines.

You will review GxP documents, support CAPAs, deviations, change controls, DS specifications, Master Production Records, and risk assessments, while contributing to SOP improvements and QA projects.

Qualifications

• Master's degree with at least two years in Quality Assurance.
• Or extensive GMP background with five years in QA.
• Experience in biopharma or CDMO is advantageous.

Responsibilities

• Batch review and release activities with QA oversight.
• QA review/approval of GxP documents (change controls, deviations, CAPAs, DS specifications, MBRs, risk assessments).
• Support generation or improvement of SOPs and QA projects.
• Possible support for client audits.

Skills

Quality Assurance

GMP knowledge

Documentation

Communication

Education

Master's degree in relevant field

Job description

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, 21 CFR 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. In this role, you will be responsible for batch review and release activities, as well as the QA review and approval of GxP documents, including but not limited to:

• Change controls
• Deviations
• CAPAs
• DS specifications
• Master Production Records
• Risk Assessments

You will also be responsible for supporting the generation of new, as well as improvement of, existing department SOPs. You will also be QA responsible for projects. If necessary, you will be supporting client audits.

The team covers an on-call duty phone, so you can expect a shift every month.

Are you experienced in GMP and curious about working in a global CDMO?

We are looking for a new colleague with either:

• A relevant Master's degree and at least two years of experience in Quality Assurance; or
• A broader GMP background with a minimum of five years of relevant experience.

Experience in biopharma or a CDMO environment is highly advantageous. We are particularly interested in candidates with hands-on experience supporting GMP manufacturing operations and batch disposition activities within a drug substance, drug product or CDMO environment.

AGC has international customers, and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent. We also focus on excellent written and verbal communication skills to internal and external stakeholders. 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.

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.