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 a new scientist with experience, preferably within API production or other areas within the pharmaceutical industry. The hire is for 12 month, but with an eye to our growth – there could easily be a position either here or elsewhere in the organization afterward if we are a good match for each other!
AGC Biologics is a Contract Manufacturing Organization (CDMO) with facilities in Denmark, Germany, Italy, Japan, the USA, and customers worldwide. We have more than 43 nationalities employed, and the daily language is English.
Our newly established team is comprised of 10 engaged colleagues that a driven by the ever-changing manufacturing pace. We strive to ensure high quality and enjoy a great team spirit.
The team will operate under cGMP and be responsible for continuous support to our dedicated adjuvant manufacturing line. The products consist of various unit operations such as buffer preparation, homogenization, filtration, tangential flow filtrations, and filling operations. We secured the compliance framework around the department, covering daily operations documentation, establishment and maintenance of SOP’s, training documentation, deviations, and CAPA management. The job has a strong focus on batch review and being able to work in a systematik manor.
- Write, review and update compliance documents, such as SOP’s
- Facilitate and conduct investigations related to process, environmental, compliance, or safety events
- Write and review deviations, CAPA’s and change requests
- Secure training 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
- 2+ years of experience from the pharmaceutical industry working in a cGMP environment
- Experience with authoring compliance documents, such as SOP’s, MPR’s, deviations, CAPA’s and change requests
- 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
As a person, you are curious, eager to learn, and a team player: You thrive in a high-paced environment where no two days are the same.
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 customers. At AGC Biologics, the work environment is informal, and humor is part of the workday. We respect each other and our differences, and we help each other reach deadlines together as one team.
For further information, please get in touch with Anna Jaroszewski, Manager, Adjuvant Support, phone +45 27602427
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.