TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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Associate Director/Director, Protein Mass Spectrometry

Department :  PD
Working place :  Hangzhou
Recruitment :  1
Nature of work :  Full-time
Working years of :  5 years and above
Minimum academic :  Master's degree and above
Release time :  16 Oct, 2020
Responsibilities
  • Team of scientists supervising the characterization group;

  • Design, development, and validation of mass spectrometry and chromatography methods for recombinant protein drugs;

  • Analysis methods reviewing and problem-solving;

  • Development and implementation of protein drug characterization assay techniques;

  • Writing and approval of characterization analysis reports, technical documents, and standard operating procedures;

  • Act as AS's representative or project leader on the project team;

  • Write and review IND, BLA and other regulatory documents;

  • Provide analytical analytical support to cell culture, purification and formulation groups to solve challenging CMC technical issues;

  • Other work arranged by superior leaders.

Qualifications
  • Research direction of protein mass spectrometry ,the Doctor's degree in chemistry, biochemistry, or related biology (more than 5 years of experience in macromolecules characterization ; or the Master's degree in biological sciences with more than 10 years of analytical research background and experience in macromolecules characterization;

  • Strong technical expertise and understanding of protein analytical chemistry methodologies, such as mass spectrometry, chromatography, and capillary electrophoresis;

  • Excellent experimental skills and ability to design experimental protocols;

  • Proficient in experimental data storage, review, and summary reporting;

  • Have the ability of Independent laboratory, but should have strong teamwork and communication skills. Excellent time management, organizational skills, and interpersonal skills;

  • In-depth understanding of analysis and regulatory requirements in mAb products. Rich experiences in writing IND, BLA and other regulatory documents of mAb or fusion protein. Experienced in global IND or BLA filing;

  • Over 3 or more years people management experience. Have excellent teamwork spirit.