Analytical scientist with experience in capillary electrophoresis (CE) and HPLC - 15 month temporary position

AGC is looking for a Scientist with expertise with icIEF, CE and HPLC for method development team.
We are seeking a scientist with a strong scientific profile within especially capillary electrophoresis techniques for a 15 month maternity leave vacancy in the HPLC team in the Analytical Development (AD) Department at AGC Biologics A/S (AGC). AGC is a Contract Manufacturing Organization with facilities in Denmark, Germany, Japan and USA and with customers all over the world.

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visitwww.agcbio.com.

The department
The AD Department is responsible for implementation, transfer and development of analytical procedures, analytical support to upstream and downstream, 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 with expertise within icIEF and CE you will be responsible for developing state of the art methods within these areas as well as UHPLC for a wide variety of protein based products to support our customers getting their product to market as fast as possible with a high quality. You will be working together with a team of 5 scientists and 8 technician’s. You will be ADs representative in projects and present the excellent methods implemented as well of the results of these. As a scientist in AD with responsibility for method implementation, transfer and development, approval of analytical data, participation in cross functional project teams and interaction with customers we can promise a diverse job with a possibility to get responsibility fast.   
 
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 28 dedicated and highly competent scientists and technicians working in two areas e.g. UHPLC and bioassay. The team is in close contact with our counterparts in our Seattle facility.

Responsibilities and tasks
As a scientist, you will be responsible for multiple methods in many analytical development projects and act as AD project coordinator. 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:
• Implementation, transfer and/or development of analytical procedure within, icIEF, Capillary electorphoreis (CE) and UHPLC.
• Representation of AD in cross-functional project teams.
• Verbal and written reporting to clients.
• Approval and reporting of analytical results to internal and external customers.
• 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 icIEF and CE methods but also regular UPLC methods like SEC, RPC, HIC, IEX etc. In addition to that you have:

• Strong experience with icIEF and CE will be required
• Several years of experience in analytics for biologics preferably from 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.
• Experience with characterization assays for biologics will be an advantage.
• An understanding of biopharmaceutical manufacturing and regulatory requirements.
• Good interpersonal and communication skills.
• Prior experience with leading small teams would be an advantage.
• 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.

For further information, please contact Lasse Olsen, HPLC/CE Team lead, Analytical Development, phone +45 2269 9432, or Helle Grann Wendelboe, Director of Analytical Development, phone +45 2294 3090.

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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