KC229 - Analytical Development QC Manager

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Posted: 10/09/2019 16:47
Start Date: Not Available
Salary: Competitive
Location: Babraham Research Campus, Cambridge, UK
Level: Management
Deadline: 11/10/2019 23:59
Hours: 35.00
Benefits: Excellent range of benefits
Job Type: Permanent

Kymab is a clinical-stage biopharmaceutical company developing a deep pipeline of novel antibody-based therapies in a broad range of indications. The Company generates its product candidates using its proprietary, integrated platforms collectively called IntelliSelect®. Kymab’s platforms have been designed to maximize the diversity of human antibodies produced in response to immunization with antigens. Selecting from a broad diversity of fully human antibodies allows for the identification of antibodies with optimal drug-like properties.

Reporting to the Group Leader of CMC Analytical Deveolpment, we are looking to bring on board a QC Manager of Analytical development to develop & run QC analytical methods to characterise product quality attributes of biopharmaceuticals.

Key Duties/Responsibilities:

  • Develop QC analytical methodologies and create SOPs for product quality analysis of monoclonal antibodies and novel biologics to support the Kymab portfolio

  • Technology Transfer to Contract Manufacturing Organisations (CMOs)

  • To provide CMC manufacturing records and documentation to support regulatory submissions

  • To communicate progress and identify risks and issues arising to the Group Leader of Analytical Development as appropriate

  • Represent the Analytical Development function on internal and external project teams

  • To maintain awareness of, and ensure compliance with, Kymab policies and procedures

Job Requirements

Education & Experience:

  • PhD in relevant discipline or BSc/MSc with equivalent industrial experience

  • Proven track record of analysing product quality attributes for biopharmaceuticals

  • Proven track record in analytical method development for mAbs and biologics

  • Proven track record in maintaining CMC documentation within a Quality Management System

Skills & Knowledge:

  • Comprehensive knowledge of qualifying (essential) and validating (desirable) analytical methods to support biopharmaceutical development (monoclonal antibodies & novel biologics)

  • Highly competent in liquid chromatography (reversed phase, size exclusion, IEX) and capillary electrophoresis technologies

  • Experience in mass spectrometry techniques, including peptide mapping and intact mass analysis, desirable

  • Ability to work independently to establish and run qualified/validated methods and to perform analytical testing as required

  • Highly organised, able to prioritise work, work well under pressure and meet deadlines

  • Excellent communication and organizational skills

  • Development and implementation of analytical capabilities

  • Maintain a high standard of professionalism when representing the Company both internally and externally

  • Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external CMOs

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