Operational Scientist, Microbial Upstream Manufacturing

AGC Biologics; Søborg; On-site; DKK 550,000 - 750,000; Full time

Job summary

AGC Biologics in Copenhagen invites an Operational Scientist in Microbial Upstream to coordinate the Upstream technician team and support daily manufacturing activities. You will work with the Supervisor and technicians to ensure smooth operations within a cGMP framework.

The ideal candidate holds an MSc in chemical engineering and has +3 years of GMP experience, with a strong analytical approach and LEAN understanding.

Qualifications

• Requires MSc in chemical engineering or similar.
• Experience in production areas within the pharmaceutical industry (GMP).
• LEAN principles knowledge is a plus.
• Business language is English.

Responsibilities

• Ensure cGMP compliance and safety for manufacturing associates.
• Coordinate production activities for technicians according to the plan.
• Assist in project preparations and cross-functional collaborations.
• Assist with training on new equipment and SOP updates.
• Support in short-term planning and daily reviews/board meetings.
• Act as SME on microbial upstream equipment and processes.
• Update cGMP SOPs and TEQs.

Skills

MSc in chemical engineering

GMP experience

LEAN principles

English fluency

Education

MSc in chemical engineering

Job description

Join our great Microbial Manufacturing team!

The Microbial Manufacturing team is part of the larger Manufacturing function, which is responsible for the production of Drug Bulk Intermediate (DBI) and Active Pharmaceutical Ingredient (API) for pre-clinical, clinical and commercial use. The team consists of approx. 68 full-time employees, covering upstream and downstream technicians and scientists.

The team you will be joining, operates under cGMP and is responsible for running the Upstream microbial manufacturing line, executing unit operations such as media preparation, Thaw and expansion, Fermentation and harvest, as well as securing the compliance framework around the department, covering daily documentation of the operations, establishment and maintenance of TEQs, SOP’s and training documentation.

You will be part of a constant cross-functional collaboration!

As Operational Scientist in Microbial Upstream, you will be supporting and helping coordinate the Upstream technician team in all production activities. You will work closely with the Supervisor and experienced technicians to ensure full courage of our manufacturing operations. There is constant collaboration across the organization, so we are looking for someone who thrives in team-work. You will, together with the Microbial team, be part of our future manufacturing success.

\"We are a collaborative and supportive team where our scientists and technicians work side by side to solve challenges and deliver results together. This in cross-functional collaboration with colleagues from Quality, Engineering and other support functions. Our department is involved in new initiatives and continuous improvements, giving you the opportunity to influence how we work and contribute with your own ideas. No two days are the same. We believe in teamwork, giving people ownership and knowledge sharing rather than working in silos. Here you will have the opportunity to make real impact, develop your expertise and join a team that values openness, collaboration and genuine willingness to help each other succeed!\" - Irene Julian Mistry, Supervisor of the team

You will get a lot of responsibility and trust in delivering on these primary tasks:

• cGMP compliance, training of your manufacturing associates and contribute to keeping a safe work environment.


• Manage production activities for the technicians according to the production plan and if needed participate in the execution.


• Coordination of preparations for each of our different projects.


• Support in training of using new equipment


• Secure short-term planning


• Secure and participate in daily reviews


• Participate in daily board meetings


• Support Supervisor when needed


• Operating as SME on the Microbial equipment and process


• Update cGMP SOPs and TEQs

You will be utilizing your Upstream understanding and skills from day one!

The ideal candidate holds an MSc in chemical engineering or similar because it enables you to understand the processes and approach your tasks in an analytical and structured manner. We are looking for a new colleague with experience within the production area in the pharmaceutical industry, preferably +3 years working in a GMP environment. It will be a great advantage if you bring scientific understanding of Upstream as well as LEAN principles.

Our organization uses English as a business language, so professional fluency is a requirement. Our work environment is dynamic and often at a high pace, so we are looking for someone who thrives well in a place like this. As a CDMO and manufacturing department, our work relies on mutual flexibility, and we truly appreciate if you are motivated by taking responsibility and leaning in!

The team is on a three-shift rotating schedule, so this is a requirement for the Operational Scientist role.

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