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The Department
The QC department at AGC biologics are responsible for supporting production of new biopharmaceuticals by controlling raw materials, performing analytical testing, environmental monitoring of productions rooms, planning and executing stability programs and validating various analytical methods according to ICH guidelines from clinical phase I to phase III and commercial.
The department consists of: QC Bioassay, QC Chemistry, QC support, QC Planning and Systems and QC Microbiology. Where QC Microbiology consists of: QC Microbiology Laboratory and QC Environmental monitoring.
The vacant position is in QC Environmental monitoring department (consisting of 8 highly dedicated technicians, 3 skilled scientists and one manager). QC Microbiology is responsible for microbiological analysis on batches for clinical and commercial samples, method validation, environmental monitoring (EM) in clean rooms, chemical/microbiological analyses on pharmaceutical water, and TOC analysis on rinse samples from production.
The department works in close collaboration with Manufacturing, QA, Up- and Downstream Development, Analytical Development and external laboratories to maintain control of all steps in the manufacturing processes. Everything we do, we do in close collaboration with our customers
Within this broad working area, many different customers’ projects and with various biopharmaceuticals the QC department differs from traditional QC labs. The position requires an engaged, ambitious leader with interest in people, knowledge of Microbiology and EM and GMP biopharmaceuticals production.
Tasks and Responsibilities
We are looking for a team leader for our team of 8 EM technicians. Your main responsibility will be to ensure that you and your team are thriving and meeting the goals of the QC department. Apart from taking care of your team, you will ensure close collaboration () and internal stakeholders as manufacturing, development, supply chain management, facility service, QC and QA.
Further, we are in progress of building a new factory at AGC. The new factory will be ready for qualifications of cleanrooms end 2023. You will be in charge for the technicians performing this qualification. This will require great coordination and close collaboration with both internal and external stakeholders.
You will be responsible for ensuring cGMP compliance and participation in customer audit and regulatory inspection of which, we as CDMO, experience a lot. This calls for a strong GMP mindset and experience.
It is pivotal that you have interest in continuous improvement and process optimization. A knowledge of EM equipment and qualification of rooms and equipment will also be a plus.
The team leader must create a positive, motivating and productive working climate in accordance with AGC biologics values. Additionally she/he must conduct employee performance appraisals and set goals. Additionally, the candidate is responsible for cross-organizational activities associated with the Manufacturing, Quality, and Development organization through the role as team leader, by conveying and reporting result of relevance from the department to stakeholders.
Your profile
In our new colleague, we are looking for a person with:
- Relevant education
- Experience with EM and microbiology quality control in biopharmaceutical production
- 3+ year experience in a regulated (cGMP) manufacturing environment
- Preferably 1+ year as a team leader or manager
- Basic knowledge of equipment and methods used for EM
- Knowledge of cleanroom qualification
- Good English communication and ability to effectively communicate with others engaging with customers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders
- Familiar with EMA, FDA, and ICH regulations for biologics and EM
- Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks.
Key responsibilities:
- Manage the flow of day-to-day operations in the technician team
- Supports requests for technical assistance from the rest of the AGC biologics organization
- Team Leader - Functions in a team setting efficiently with other team members and team lead peers within QC Environmental monitoring
- Monitor technician team member’s participation, engagement, and performance to ensure individual performance in the team setting
- Communicate clear instructions and feedback to team members and listen to team members' feedback
- Facilitate and or provide training for team members on a needed basis
- Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards
- Reports and updates to department manager on the team's progress
- Assists manager of department in department and scientific efforts as needed.
The daily challenges will vary a lot, and two days will never be the same
AGC offers
AGC biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will largely be able to plan your daily work on your own. AGC biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.
We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the add will close. We are therefore looking forward to receive your application today!
For further information regarding the position, please contact. Manager, Jakob Knudsen at +45 27 60 30 29.
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.
Visit www.agcbio.com to learn why AGC biologics is a World Leader in process development and contract manufacturing.
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 19.7.2023, men kan have været deaktiveret og genaktiveret igen.
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