Technician, Analytical Development

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Technician for Analytical Development For Danish version – see below AGC is looking for a technician with expertise and experience in characterization of protein-based biotherapeutics.
We are seeking a technician with an interest in analytical characterization of biotherapeutics, by employing methods such as peptide mapping by LC-MS/MS, intact mass analysis by mass spectrometry, N-linked glycan analysis by HILIC-FLD and quantification of detergents by LC-CAD detection.

The position will be anchored in the Characterization Team in the Analytical Development (AD) Department at the Copenhagen site of AGC Biologics A/S (AGC). AGC is a Contract Development and Manufacturing Organization with facilities in Denmark, Germany, Italy, Japan and USA and with customers all over the world.

The Department
The AD Department consists of 42 dedicated and highly competent technicians and scientists working in four sub teams; characterization, chromatographic assay development, bioassay development and PD support. AD is responsible for:

• Implementation, transfer and development of analytical procedures
• Transfer of analytical methods to QC for validation
• Analytical support to upstream and downstream process development departments
• Characterization of biotherapeutic products and drug intermediates
• Testing engineering batches for production

AGC projects range from early pre-clinical development through all phases of clinical development to commercial supply. AD is also involved in cross-functional project groups and implementation of new analytical technologies and techniques. The AD department is in close contact with our counterparts in our Seattle (USA), Boulder (USA), Heidelberg (GER) and Chiba (JPN) facilities.

As a technician in the Characterization team, you will be working with developing analytical methods in several different characterization assays like intact mass analysis, peptide mapping and glycan analysis as well as various chromatographic techniques. All in the quest to support a wide variety of protein-based drug products to support our customers getting a high-quality product to market as fast as possible. You will be working together with a team of 3 scientists and 3 technicians, and we can promise an exciting and diverse job.

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.

Responsibilities And Tasks
You will get the opportunity to work with a broad range of personalities as well as a diverse set of drug products in different clinical stages; you will also get the opportunity to use your skills in a cross-functional setting and interactive environment.

The Job Includes

• Evaluating methods received from clients before method implementation at AGC.
• Develop analytical characterization methods for challenging biopharmaceuticals, including documentation of the methods.
• Perform "pre"-validations ensuring methods are suitable for use in QC.
• Running analytical assays to generate data to support upstream and downstream process development.
• Independent processing of analytical data and preparing it for scientist review.
• Troubleshooting of analytical methods and instruments.
• Instrument responsibilities.

Experience And Competencies
The ideal candidate is an educated lab technician or has an equivalent scientific/technical background. You have practical experience with executing methods within LC-MS and/or chromatographic methodologies of proteins. In addition to this you have:

• +4 years of experience in analytics, preferably from the biotech industry.
• Understanding of analytical instrumentation.
• Understanding of biopharmaceutical manufacturing and regulatory requirements.
• Ability to work independently in a dynamic environment.
• Good interpersonal and communication skills.
• Good English communication skills both oral and written.
• Computer skills.
• Experience in Chromeleon will be an advantage.

Application
For further information regarding the position, please contact Team lead Esben Trabjerg either by email etrabjerg@agcbio.com or phone: +4522943097. We treat the applications as we receive them and conduct interviews with qualified candidates. When the right candidates are found, the add will close. Laborant til analytisk udviklingsafdeling AGC er på udgik efter en laborant med ekspertise og erfaring indenfor karakterisering af proteinbaserede biologiske lægemidler Vi er på udgik efter en laborant med interesse for analytisk karakteriserings af biologiske lægemidler. Du vil komme til at arbejde med peptide mapping ved LC-UV og LC-MS/MS, intakt masse analyse ved LC-MS/MS, analyse af N-linkede glykaner ved HILIC-FLD og kvantificering af detergenter ved LC-CAD detektion. Stilling hører hjemme i karakteriseringsteamet i den analytiske udviklingsafdeling (AD) i AGC Biologics (AGC) faciliteter i Søborg, København. AGC er en kontraktudviklings- og produktionsorganisation med faciliteter i Danmark, Tyskland, Italien, Japan og USA og med kunder over hele verden. Afdelingen AD afdelingen består af 42 dedikerede og yders kompetente laboranter og scientists, der arbejder i fire teams; karakterisering, udvikling af kromatografiske assays, udvikling af bioassay og PD-support. AD er ansvarlig for:

• Implementering, overførsel og udvikling af analytiske assays.
• Overførsel af analytiske metoder til QC for validering.
• Analytisk støtte til Upstream og Downstream procesudviklingsafdelinger.
• Karakterisering af biologiske lægemidler og intermediater.
• Test af Engineering batchs for produktionen.

Projekterne i AGC spænder fra tidlige præ-kliniske fase til produktion for det kommercielle marked. AD er også involveret i tværgående projekter og implementeringen af nye analytiske metoder. AD er i tæt kontakt med vores søsterafdelinger i Seattle (USA), Heidelberg (GER), Boulder (USA) og Chiba (JPN). Som laborant i karakteriseringsteamet vil du komme til at arbejde med række forskellige karakteriserings analyser som, intakt masse analyse, peptid mapping, glykananalyse og forskellige kromatografiske metoder. Teamets vigtigste opgave er at deltage i udviklingen en lang række forskellige biologiske lægemidler og sørge for, at vores kunder får fremstillet et høj-kvalitetsprodukt, som kommer på markedet så hurtigt som muligt. Karakteriseringsteamet består af 3 forskere og 3 laboranter, og vi tilbyder en spændende og afvekslende hverdag. Arbejdsmiljøet i vores afdeling er meget uformelt, og der er bredt forankret samarbejdet over og gennem afdelingen mellem laboranter, forskere og ledelse. Alle medarbejdere har en professionel og fleksibel indstilling til deres arbejde. Ansvarsområder og opgaver
Du vil få muligheden for at samarbejde med en bred vifte af forskellige personligheder og få genskab til mange forskellige biologiske lægemidler fra alle kliniske faser. Desuden vil du få mulighed for at benytte dine færdigheder i tvær-funktionelle projekter i et dynamisk miljø. Jobbet indeholder blandt andet:

• Evaluering af analytiske metoder modtaget fra kunder til implementering hos AGC.
• Udvikle analytiske karakteriserings metoder for udfordrende biologiske lægemidler, herunder dokumentation af metoderne.
• Udføre præ-validering og sikre at analytiske metoder er egnede til brug i QC.
• Udføre analytiske metoder for at genere data til at hjælpe procesudviklingen i Upstream and Downstream udviklingsafdelingerne.
• Selvstændig bearbejdning af analytiske resultater og data og forberede dette til gennemgang af en scientist.
• Fejlfinding af analytiske metoder og instrumenter.
• Ansvarlig for analytisk udstyr.

Erfaringer og færdigheder Den ideelle kandidat er uddannet som laborant eller har en tilsvarende videnskabelig/teknisk baggrund. Du har praktisk erfaring med at udføre analytiske metoder af proteiner på LC-MS udstyr eller andre kromatografiske metoder. Derudover har du:

• +4 års erfaring med analytisk kemi, gerne fra biotekindustrien.
• God forståelse af analytisk udstyr.
• En forståelse for produktion af biologiske lægemidler og regulatoriske krav.
• Mod på at arbejde selvstændigt i et dynamisk miljø.
• Gode sociale og kommunikative evner.
• Gode engelske kundskaber både i tale og skrevne.
• IT-kundskaber.
• Kendskab til Chromeleon og Thermo LC-udstyr vil være en fordel.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook ! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.