Copenhagen, Denmark

Would you like to be a part of AGC Biologics growing success?
At AGC Biologics A/S we work with development and GMP manufacturing of APIs for both commercial products and products in all clinical phases. We are a client centric CDMO, and the partnership with our clients, working side by side with the clients, is our focus.

We are looking for a manager for our Support & Compliance team of engineers/scientist providing technical support to our current facilities and our new EUR 160 million Mammalian Manufacturing Facility that is scheduled to start operation during 2023. AGC Biologics is in a period of rapid growth and you will play an important role in getting our new facility ready to continue our growth journey.

The new Mammalian Manufacturing Facility will be designed for production of Drug Bulk Intermediate and Active Pharmaceutical Ingredient for pre-clinical, clinical and commercial use.

The department
You will be part of the Engineering and Operations Support (EOS) department responsible for execution of technical projects including facility projects as well as operation of all utility and facility systems, maintenance and calibration across our current facility. We also have the responsibility for the reception and service team. The department consist today of around 45 employees with project managers, engineers, compliance specialist and technicians and will grow further during the coming year.

The position
The manager for Support & Compliance in EOS will support that AGC requirements are fulfilled for a range of utility and support systems in the new facility. Examples of utility and support systems are WFI, purified water, clean gas systems, cooling systems, facility steam, SCADA and BMS system, HVAC, and electrical installations.

In the current facility the Support & Compliance team supports the technician in the department related to complex trouble shooting activities. The team drives all quality related task such a deviations, technical system changes, CAPAs, and procedures as well as our electronic maintenance systems. The team also manage various improvement and system upgrade projects.

The Support & Compliance team consists of 8 employees with engineering related background.

You will ensure both performance and well-being of your team through your management style and general involvement and dialogue with your team.

You will also ensure training of your team – including that the relevant competencies are present to be able to handle audit and inspection presentations. You will also personally present at audits, when the necessary introduction is completed.

As part of the EOS department you can expect many and varied types of tasks, with a large contact interface to internal stakeholders and some external partners.

Your profile

• Relevant Engineering degree - preferably within the mechanical or chemical area
• Prior management experience – either line or project management
• 5+ years of operations or engineering experience in the biopharmaceutical industry including experience working under GMP.
• Experience with some of the utility systems mentioned above.
• You have hand-on experience from writing procedures and handling quality tasks (e.g. deviations and change request)
• Knowledge about automation and control systems.
• Experience from facility projects – either on the end user side or from an engineering company.
• The ability to work effectively under pressure and high flexibility to meet demand in the role
• Good communication skills – including the ability to communicate clearly and professionally in written and spoken English and Danish is preferred
• Knowledge of the qualification process for pharmaceutical manufacturing facilities
• You operate with strong sense of urgency and a positive can do attitude.

How to apply
Send your application as soon as possible as we process the applications as we receive them.

If you need further information about the position, please feel free to contact Jesper Sandholm Hansen, Senior Director of EOS +45 2557 8027.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.