id: NDk4MDA1NCA3

reference: 4980054

documentId: 4980054

connectionPointId: 7

lastModificationDate: 1556541032340

stillingsbetegnelse: Team Lead / QC Chemistry Scientist

jobbeskrivelse:

GC 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, visit www.agcbio.com.

 

SUMMARY:

AGC Biologics is looking for a Team Lead / QC Scientist for the QC Chemistry/HPLC Group to lead a team of seven highly dedicated Technicians. The Team Lead / QC Scientist position requires people management, communication skills, technical expertise and ability to troubleshoot on chromatographic methods, especially HPLC, iCIEF and CGE -SDS. In addition to leading a team, you will also represent QC as Scientist in customer project teams, preparing for method validation (clinical phase I/II through full validation) and commercial licensing. You will be a part of the QC department that consists of three functional groups: QC Bioassay, QC Chemistry and QC Microbiology. Become part of an international and modern organization that delivers biopharmaceutical development and manufacturing, in an informal working environment, where high energy and enthusiasm is part of the daily work life.

PRINCIPAL RESPONSIBILITIES:

• Lead a team of seven Technicians.

• Represent Quality Control as a Scientist.

• Prepare Method Validation for both clinical phase I/II through full validation and commercial licensing.

• Responsible for supporting the production of new biopharmaceuticals by controlling raw materials, performing analytical procedures according to ICH guidelines.

• Participate in many different customer projects and with various biopharmaceuticals.

• Collaborate closely with customers and internal departments to gain control of all steps in the manufacturing processes.

• Improve laboratory GMP systems according to European and US regulatory guidelines.

KNOWLEDGE, SKILLS & ABILITIES:

• People management skills

• Working and troubleshooting experience with SE-, IEX- and RP-HPLC, iCIEF and CGE-SDS analysis.

• Experience and knowledge with (U)HPLC equipment and Chromeleon software

• Technical experience in protein analytics testing

• Knowledge of protein structure and biochemistry

• Experience with writing validation protocol, validation report, SOP’s is an advantage

• Knowledge of GMP systems according to European and US regulatory guidelines is anadvantage

• Ability to apply organizational skills to systems and efficiency improvement.

• Ability to share your knowledge and communicate openly and professionally both internally and with external customers.

• Ability to handle multiple tasks simultaneously.

• Capacity to work in a high pace environment.

• Be a leader and team player combined with the ability and desire to work independently.

• Excellent communication, presentation and interpersonal skills.

• Speak and write English at mothertongue level.

EDUCATION/EXPERIENCE:

• MSc or PhD degree in Biochemistry, Chemistry or relevant areas.

• Minimum 5 years of work experience in analytical development and/or quality control.

 

For further information regarding the position, please do not hesitate to contact Director QC Chemistry, Iben Schildt Sørensen, telephone +45 2294 2949.

We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than May 8, 2019. We treat the applications as we receive them, and qualified applicants can expect to be interviewed before the deadline.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.  EOE

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2269

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: AGC Biologics A/S

source: DK-STAR