Great Location
Competitive Salary
Performance Bonuses

Manager, Quality, GMP

Vacancy Salary £Competitive
Vacancy Location Cambridge
Mergefield Title {Mergefield Value}
Mergefield Title {Mergefield Value}

This is a Permanent, Full Time vacancy that will close in {x} days (x will be populated when viewing published adverts).

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.

To ensure GMP related activities performed at Kymab or on its behalf at contract organisations are performed to appropriate standards

Key Responsibilities:

  • Contribute to the implementation and improvement of the Quality Management System (QMS) as an enabler to delivery of Kymab’s programmes, with specific emphasis on GMP requirements.
  • As part of the Quality Team, assist in ensuring that the QMS meets all relevant regulatory requirements, with specific emphasis on GMP compliance.
  • As part of the Quality team, develop the QMS tools to ensure ongoing efficient support to client groups.
  • To provide support and advice to Kymab Development teams to ensure the logical, risk-based, application of GMP principles, as relevant, to existing or new activities within Kymab.
  • As part of the Quality Team, to deliver training in QMS tools and aspects of GMP relevant to Kymab Development functions.
  • To provide support and compliance advice to Kymab Development teams with regards to management of GMP quality issues.
  • To use a risk-based approach regarding the assessment of quality issues so as not to compromise or impede progress of Kymab’s programmes.
  • As part of the Quality Team, ensure QMS-related actions are communicated to client groups and progress tracked within the QMS.
  • Support Development Subject Matter Experts to ensure external contracted organisations supporting Kymab GMP activities are selected and responsibilities defined and documented according to Kymab procedures.
  • When working with GMP subcontractors, work with the VP Quality to ensure quality responsibilities are defined and documented, putting in place appropriate agreements as necessary.
  • Review Product Quality critical information (e.g. batch records, reports) generated within Kymab or its sub-contractors to ensure appropriate standards are maintained in accordance with any relevant procedures and agreements in place.
  • With the relevant CMC Project Managers and or relevant Kymab Subject Matter expert, monitor and manage the performance of GMP subcontractors.
  • With the VP Quality, ensure appropriate compliance oversight of Kymab Development groups and GMP subcontractors, including periodic assessment and audit as relevant.
  • To maintain awareness of, and ensure compliance with, Kymab policies and procedures relating to quality standards within the Company.
  • Assist the QMS Manager in ensuring issues and metrics are communicated effectively to Kymab management.

 

Job Requirements:

Education and Experience:

  • Educated to degree standard, A-level or equivalent.
  • Significant experience working within a GMP environment.
  • Experience in the manufacture of biologic drug substances and /or aseptically manufactured drug products.
  • Experience in the manufacture of products for use in clinical trials.
  • Experience in overseeing, including audit of, GMP subcontractors or suppliers would be an advantage.

Skills and Knowledge:

  • Conversant with relevant industry guidance including, for example, ICH biologics guidelines.
  • In depth knowledge of cGMP and related regulatory guidelines governing the manufacture of biologics in the UK, EU & USA.
  • Highly developed interpersonal skills including communication and influencing skills.
  • Working knowledge of industry standard Quality Management Software.

Competencies:

  • Highly organised self-motivator, able to prioritise activities, work well under pressure and meet deadlines.
  • Ability to find pragmatic solutions for quality issues in a highly agile biotech environment.
  • Ability to work flexibly, collaboratively.
  • The ability to interrogate and analyse systems to identify new ways of working.

We are a young, passionate and determined company.

We want to succeed in our aims to make a difference in healthcare and make better medicines using our unique technologies.

Our headquarters are in Cambridge, UK, on the Babraham Research Campus, an established bioscience campus, home to more than 60 companies.

Since we were founded, our team has grown to more than 180 people. It’s an invigorating environment where our teams work closely and collaboratively to help us all to achieve our aims.

You’ll find your role at Kymab exciting, interesting and stimulating, with the opportunity to interact with a diverse range of colleagues, both internally and externally.

Great Location

Competitive Salaries

Performance Bonuses

Share Plan

Healthcare Cover

Life & Income Insurance

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Published

2 hours ago

Closing

14 Days
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