We are seeking a scientist with a strong profile within qualification of analytical equipment for protein analysis focused on HPLC, PA 800 Plus, iCE3/Maurice, Caliper, Octet, SoloVPE, qPCR equipment to GMP level in the Analytical Development (AD) Department at AGC Biologics A/S (AGC). AD has 4 equipments that we right now have not been able to unpack and qualify. This position has been created to continuously optimize the equipment we use for our analysis.

AGC is a Contract Manufacturing Organization with facilities in Denmark, Germany, Italy, Japan and USA and with customers all over the world.


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 for which qualified equipment is a very important part. 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 specialist for qualification of equipment in Analytical Development you will be responsible for implementing new equipment and getting it to work. This will include but not be limited to equipment for new technologies and equipment to increase our current install based to be able better support our growing project portfolio. The qualified equipment will be utilized for analytical implementation and support on 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 15 scientists and 22 technician’s. You will be ADs qualification expect and work together with QA and QC on controlling our instrument park as well as coming up with new ideas to what potentially could reduce our analytical TAT time further.

As a specialist in AD with responsibility for equipment qualification, you will be responsible for Change Requests, User Requirement Specification, TEQs and IQ/OQ/PQ protocols and report as well as vendor contact and QA involvement. You will also be involved in the department scouting for new equipment technologies based on placed in Seattle.

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 37 dedicated and highly competent scientists and technicians working in four sub team; HPLC/CE development, bioassay development, process development support and characterization. The team is in close contact with our counterparts in our Seattle facility.


Responsibilities and tasks
As a qualification specialist, you will be overall responsible for all AD equipment new and existing. You will participate in cross organization collaboration with Upstream, Downstream, Process Transfer, QC and QA.

You will get the opportunity to work with a broad range of personalities as well as diverse equipment’s in different qualification stages and to use your skills in a very cross-functional setting and interactive environment.


The job includes:
Transfer, development and Implementation of analytical procedure within HPLC and Capillary electrophoresis (CE).
  • Qualification of analytical equipment
  • Vendor contact and planning.
  • Create supporting documents
    • Change Requests
    • User Requirement specifications
    • TEQ’s
    • IQ/OQ protocol
    • IQ/OD reports
    • Logbooks
  • Collaboration with QC and QA
  • Collaboration with other departments
 
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 and electrophoretic methods in a protein context.
 
In addition to that, you have:
  • Several years of experience with qualification of analytical equipment preferably from the biotech industry.
  • Strong expertise within documentation of equipment qualification.
  • Strong understanding of the workings of analytical instruments and how instrument variables affect assay performance.
  • Strong cross-functional expertise and understanding of how analytical equipment best capture/monitor potential impacts to the quality and functional activity of proteins during the production process.
  • Experience with characterization equipment used for biologics will be an advantage.
  • An understanding of biopharmaceutical manufacturing and regulatory requirements.
  • 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. You 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.
 

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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.

 

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