Scientist, QA Microbial (9 months cover)

AGC Biologics; Søborg; On-site; DKK 540,000 - 760,000; Full time

Job summary

AGC Biologics in Søborg, Denmark, is seeking a QA Scientist to join the QA Microbial team on a fixed-term maternity cover of nine months. The role focuses on ensuring quality assurance of manufacturing activities and patient safety across the biotechnological production processes.

You will review and approve technical documents (BPRs, change controls, deviations, CAPAs, DS/MPRs, risk assessments), support SOP development, and assist withQuality Agreement negotiations and client audits in a

Qualifications

• Master’s degree in a science field.
• Experience with QA and GMP in biopharma.
• Fluency in written and spoken English.
• Experience supporting manufacturing at a drug substance or product site.

Responsibilities

• QA review and approval of technical documents (BPRs, change controls, deviations, CAPAs, DS specs, MPRs, risk assessments).
• Help develop and improve SOPs within the department.
• Assist with Quality Agreement negotiations with clients and support client audits.

Skills

QA experience

GMP knowledge

English fluency

Education

Master's degree in a science field

Job description

Are you passionate about Quality Assurance (QA) and GMP, and would you like to make a real impact on manufacturing activities and ensure patient safety in our global CDMO environment? We are looking for a QA Scientist to join our QA Microbial team and assist with quality assurance of our biotechnological production. If you enjoy teamwork and international customer engagement, read more below. Please note that this position is offered as a fixed-term maternity cover for nine months.

Join a collaborative team in the QA Operations department!

QA Operations consists of multiple sub-teams with the main responsibility of quality assurance of manufacturing activities and batch release of microbial manufacturing of drug substances (API) and cell banks. We actively work within our field of understanding and interpreting legislation to ensure that manufacturing complies with current standards for GMP production, including EU GMP, 21 CFR and ICH guidelines. We continuously improve our standards within quality and manufacturing processes, innovate through modern technology and strengthen our common value chain with internal stakeholders.

Our department is open-minded and has a high service level for our colleagues throughout the AGC Biologics organization—and not least for our international customers. Our colleagues are characterized by positivity and proactivity, and we meet deadlines through committed and friendly collaboration and open communication with a focus on a high level of professionalism.

\"You'll join a highly engaged QA Microbial team where quality, collaboration, and continuous improvement are at the heart of everything we do! We work closely across functions to ensure patient safety and product quality, while fostering a supportive environment where every voice is valued and every contribution makes a difference!\" - Nazeer Roya, Manager, QA Microbial

You will quickly be responsible for QA review

Your daily responsibilities include ensuring the resolution of significant quality issues with the client through the coordination and collaboration of internal functional resources. You will identify, propose and carry out efficient plans to resolve issues while protecting product quality and patient safety. You will be responsible for the overall QA review and approval of technical documents, including but not limited to:

• Batch Production Records (BPRs)
• Change controls
• Deviations
• CAPAs
• DS specifications
• Master Production Records
• Risk assessments

In addition, your responsibilities include supporting the development of new department SOPs and the improvement of existing SOPs. You will be liaising with internal and external stakeholders, including management, to resolve and clarify issues. If required, you will be assisting with the negotiation of Quality Agreement terms with clients, and supporting client audits.

Are you passionate about QA and pharmaceutical manufacturing?

AGC has international customers, and our company language is English. Therefore, fluency in both written and spoken English is required, especially because this role will be communicating with internal and external stakeholders. We are looking for a colleague who brings a relevant science-based Master’s degree and experience with QA and GMP from the biopharmaceutical industry, preferably from a role working in or directly supporting manufacturing at a drug substance or drug product manufacturing site. This combination of competencies typically translates into a few years of experience.

It is of utmost importance that you have a self-motivated personality with a proactive and pragmatic attitude to your daily work—without compromising on quality. The environment is dynamic and challenging, requiring the ability to find solutions, deliver on promises and provide our customers with a positive experience. Our colleagues are competent prioritizing and balancing multiple tasks at a time and meeting deadlines, making them work very effectively in this fast-paced, matrix environment. We are looking for a colleague with the same personal characteristics and flexibility, and who wants to develop even further to meet changing needs and priorities of the business, because this is the nature of our organization.

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.

Location: Copenhagen Site

Are you passionate about Quality Assurance (QA) and GMP, and would you like to make a real impact on manufacturing activities and ensure patient safety in our global CDMO environment? We are looking for a QA Scientist to join our QA Microbial team and assist with quality assurance of our biotechnological production. If you enjoy teamwork and international customer engagement, read more below. Please note that this position is offered as a fixed-term maternity cover for nine months.