*Scientist for Reference Material
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The Department
The QC organization consists of six departments: QC Bioassay, QC Chemistry, QC Microbiology, QC Stability, QC Automation, Digitalization, Planning and QC Raw Materials. QC are responsible for release testing of clinical and commercial batches, and validation of the analytical methods, as well as analysis of raw materials and stability programs. We are working in an international and customer oriented way to secure fast and reliable manufacturing of medicines to our customers.
Role and Responsibilities
As Responsible Scientist you will take leadership within the Reference Material area, and will support the scientists within QC on strategies for establishment of reference material samples and inventory control. Moreover, as the company is changing from an early phase to late phase/Commercial production facility, the processes and procedures within the Reference Material area must continuously be improved to ensure compliance with regulatory guidelines.
In addition, responsibilities include:
Inventory
- Monitor the Reference Material and Critical Reagents inventory, in collaboration with reference material team.
Material Qualification and Lifecycle Management
- Write qualification protocols and reports, specifications as well as CoAs for Reference Materials
- Ensure on-time delivery of quality documents related to QC activities
General
- Manage multiple projects based on priority
- Interactions with customers to ensure the right strategy for their Reference Materials
- Collaboration with multiple stakeholders including QC Scientists, Project Managers, QA, as well as the Customers
- Ensure compliance with cGMP
- Key player during regulatory inspections and customer audits
- Document work accurately, clearly, and in compliance with client’s requirements
- Master’s degree in biology, chemistry, or other related degree concentration, or equivalent directly-related experience
- Minimum of 2 years GMP lab experience
- 3 years of relevant experience
Qualifications
The ideal candidate would possess:
- Knowledge within area of reference material and related guidelines
- Experience with regulatory Inspections (e.g. FDA and DMA)
- Thorough experience working in a GMP environment and understanding of regulatory guidelines
- Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
- Strong computer, scientific, and organizational skills
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- A strong understanding of analytical methods
- At least 2 years of technical writing related to the pharmaceutical industry and relevant experience reviewing
Basic Minimum Qualifications:
- Master’s degree in biology, chemistry, or other related degree concentration, or equivalent directly-related experience
- Minimum of 2 years GMP experience
- 3 years of relevant experience
- Fluent in written and spoken English
Application
Submit your application as soon as possible. We treat the applications as we receive them and conduct interviews with qualified candidates. When the right candidates are found, the add will close.
For further information regarding the position, please contact Manager Anne Lykkegaard Widlund, QC Bioassay Cell and support, at +45 2760 2154
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 to a large extent 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.
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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.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 16.10.2022, men kan have været deaktiveret og genaktiveret igen.
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- København
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