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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 Team Leader to manage the Support & Compliance team of engineers providing support to our current facilities and our future EUR 160 million Mammalian Manufacturing Facility. AGC Biologics is in a period of rapid growth and you will play an important role in getting new capacity running 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 a part of the Plant Engineering 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 and new facilities. The department consists today of around 50 employees with project managers, engineers, compliance specialist and technicians.
The team
The open position is for a Team Leader managing the team of highly skilled compliance engineers/senior engineers. The team is responsible for compliance support on the daily operations as well as on more complex facility/utility modification projects. The main tasks include elaboration and delivery of quality documentation such as Deviations, CAPAs and Change Control records, maintenance and improvement of procedures owned by the department, compliance and technical support in relation to more complex troubleshooting activities as well as presentation of quality documentation during audit and inspections. The team comprises of six engaged colleagues that are driven by the ever-changing engineering pace. We strive to ensure a high quality mindset and enjoy a great team spirit.
The position
As a Team Leader for Support & Compliance in Plant Engineering, it will be your responsibility to support the team to assure that requirements are fulfilled for a range of manufacturing equipment, utility and support systems (such as WFI, purified water, clean gas systems, cooling systems, facility steam, SCADA and BMS system, HVAC, and electrical installations) in the current and new facility.
You will be responsible for:
- Ensuring timely handling of tasks
- Ensuring KPI delivery and follow-up
- Creating clear direction for your team
- Ensuring good and valuable collaboration with all stakeholders
- Ensuring proper training and development of your team
- Ensuring good performance and well-being of your employees through your management style and involvement in the dialogue with your team
- Optimization and standardization of work processes
As part of the Plant Engineering department you can expect many various types of tasks, with a large contact interface to internal stakeholders and some external partners. You will be also personally present at audits and authority inspections, when the necessary introduction is completed.
Your profile
The ideal candidate has relevant Engineering degree and experience from previous management positions preferably in the pharmaceutical or biotech industry. Hands-on experience and knowledge in the area of GMP compliance and quality documentation (Deviations, CAPAs and Change Requests) is preferred. Experience with utility systems, control systems and facility projects is an advantage for this position.
Furthermore, the ideal candidate have the right “can-do” attitude, is eager to learn and enjoys working in a fast-paced environment.
As a person you are driven by continuous improvement, you set clear directions for your team and encourage development. You are curious and you possess good communication skills including the ability to communicate professionally in written and spoken English, and you are a team player. You operate with strong sense of urgency and you have the ability to work effectively under pressure and high flexibility to meet demand in the role.
AGC Biologics offers
AGC Biologics offers a dynamic working place with good opportunities for working with varied array of tasks and challenges. This opens many doors for personal development and enables to make a real difference towards the patients and customers. At AGC Biologics the work environment is informal and humor is part of the work day. We respect each other and our differences and help each other to deliver on time as one team.
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 Beata Jonach, Manager of Support & Compliance in Plant Engineering. +45 2269 9460.
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
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.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 15.2.2023, men kan have været deaktiveret og genaktiveret igen.
- Afdelingsleder
- København
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