*HPLC/CE Scientist for Analytical Development - Process Development Support
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The department
The AD Department is responsible for implementation, transfer and development of analytical procedures, analytical support to upstream and downstream process development, characterization of products, testing engineering batches for production and the transfer of analytical methods to QC for validation. AGC projects range from early pre-clinical development through all phases of clinical development all the way to commercial supply. AD is also involved in cross functional project groups and implementation of new analytical technologies and techniques.
As a scientist in the Process Development (PD) Support team, with expertise within HPLC and CE, you will primarily be responsible for oversight and reviewing of data from state of the art methods within these areas, supporting our customers in getting their products to market as fast as possible with high quality. You will be working together with a team of 5 scientists and 8 technicians. As a scientist in AD with responsibility for approval of analytical data as well as method troubleshooting and transfer, you may be called on to represent AD in projects and present the methods implemented as well of the results of these. Participation in cross functional project teams and interaction with customers promises a diverse job with a possibility to get responsibility quickly.
The work environment in our department is very informal. There is constant collaboration across the organization, and all employees have a professional and flexible attitude towards their work. The department consists of 50 dedicated and highly competent scientists and technicians working in four team, broadly covering Characterization, HPLC/CE Implementation, Bioassay Implementation, and PD Support (with HPLC/CE and Bioassay subteams).
Responsibilities and tasks
As a scientist, you will be responsible for multiple methods in many analytical development projects and may act as AD project coordinator in some. You will participate in multi-disciplinary project teams including Upstream, Downstream, Process Transfer, QC, QA and Manufacturing scientists working in close collaboration with the clients’ scientific teams.
You will get the opportunity to work with a broad range of personalities as well as diverse products in different clinical stages and to use your skills in a very cross functional setting and interactive environment.
The job includes:
- Approval and reporting of analytical results to internal and external customers.
- Troubleshooting of analytical HPLC and CE methods
- Representation of AD in cross-functional project teams.
- Verbal and written reporting to clients.
- Defining product specification together with QC and the client.
- Transfer of analytical procedures to QC.
- Strategic technology development together with the department.
Experience and competencies
The ideal candidate holds a PhD in Protein Chemistry, Biochemistry, Biochemical or Chemical Engineering, or related scientific/technical background with expertise in Chromatographic methods especially HPLC and CE methods, e.g. SEC, RPC, HIC, CIEX, AIEX. etc.
In addition to that you have:
- Several of years of experience analytics for biologics from the industry
- Strong expertise within development of analytical procedures.
- Strong cross-functional expertise and understanding of how analytical methods best capture/monitor potential impacts to the quality and functional activity of proteins during the production process.
- Strong experience inside HPLC and CE will be required
- Experience with characterization assays for biologics will be an advantage.
- An understanding of biopharmaceutical manufacturing.
- Experience in working with development of analytical procedures will be an advantage.
- Good interpersonal and communication skills.
- Excellent English written and oral communication skills.
On a personal level we expect you to:
Be a high performing team player and to be ambitious on behalf of yourself and the company. You master the balance between speed of execution and quality of work. You embrace change and enjoy a rapid pace of work with a positive, can-do attitude and with a good sense of humor. Think of last minute changes as a positive variety in the daily work. You are driven by achieving results through others and are good at presenting results in a convincing manner.
AGC offers
AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.
For further information, please contact Keith McCall, Manager, Analytical Development, Process Development Support, phone +45 2760 3041.
We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than August 11th, 2023.
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 "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 20.10.2023, men kan have været deaktiveret og genaktiveret igen.
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