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Manufacturing specialists for the Adjuvant Manufacturing Team

Are you passionate about providing innovative solutions to complex challenges? Do you want to be part of a company helping customers bring new advanced biological products to market? Then join a dynamic and international company where everyone is responsible for delivering right on time as one team!

With AGC Biologics increasing activities, we are looking for new scientists with experience preferably within API production or other areas within the pharmaceutical industry.

AGC Biologics is a Contract Manufacturing Organization (CDMO) with facilities in Denmark, Germany, Japan and USA and with customers from all over the world. We have more than 30 nationalities employed and the daily language is English.

The Adjuvant Manufacturing Team
The Adjuvant Manufacturing team is part of the larger Manufacturing function, which are responsible for the production of Drug Bulk Intermediate (DBI) and Active Pharmaceutical Ingredient (API) for pre-clinical, clinical and commercial use.

The team is under establishment and the manufacturing line is currently under construction. The line will be operational from 01NOV2020 and when fully staffed the department will consist of approx. 40 full time employees, covering shift supervisors, manufacturing specialists and manufacturing associates (operators).

The team will operate under cGMP and be responsible for running our dedicated adjuvant manufacturing line, executing unit operations as buffer preparation, homogenization, filtration, tangential flow filtrations and filling operations. As well as securing the compliance framework around the department, covering daily documentation of the operations, establishment and maintenance of SOP’s, training documentation, deviation and CAPA management.

The position
As 1 of 4 manufacturing specialists in the Adjuvant Manufacturing team, you will become a process specialist on the adjuvant process. You will be responsible for:

• Operating as the SMEs on the adjuvant process
• Write, review and update compliance documents, such as SOPs and MPRs
• Monitor process performance and delivery on time in full metrics
• Facilitate and conduct investigations related to process, environmental, compliance or safety events
• Write and review deviations, CAPAs and change requests
• Secure training of supervisors and manufacturing associates
• Approve batch documentation and prepare for batch release
• cGMP compliance, training of your manufacturing associates and a safe work environment
• Support the team preparing for regulatory inspections and audits
• Participate in board meetings, KPI delivery and follow-up
• Optimization and standardization of work processes.

Experience and competencies
The ideal candidate holds an academic degree within downstream processing and have previously been working in a manufacturing team operating under cGMP preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences:

• A few years of experience from the pharmaceutical industry working in an cGMP environment
• Scientific understanding of tangential flow filtrations, lipid technologies and emulsions is an advantage
• Experience with authoring compliance documents, such as SOPs, MPRs, deviations, CAPAs and change requests
• Experience with automated filtration systems and electronic batch records
• Experience with disposable manufacturing equipment
• Strong communication skills (English)
• Structured and analytical oriented
• Experience with applied Lean and a genuine interest in being close to the manufacturing floor and understanding the need for process confirmation

AGC Biologics offers
AGC Biologics offers a dynamic working place with good opportunities for working with a varied array of tasks and challenges. This opens many doors for personal development and for you to make a real difference towards both patients and customer. At AGC Biologics the work environment is informal and humor is part of the work day. We respect each other and our differences, and we help each other to reach deadlines together as one team.

For further information, please contact Christian Christensen, Vice President, Technical Operations, phone +45 41703530.

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!

About AGC Biologics
AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan 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.
AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of AGC Biologics’ innovative approach to cell line and process development.

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


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