KC252 - (Senior) Manager, Clinical Supplies

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Posted: 07/02/2020 10:30
Start Date: Not Available
Salary: Competitive
Location: Babraham Research Campus, Cambridge, UK
Level: Operations
Deadline: 27/03/2020 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.

We are looking to bring on board an experienced individual at Manager or Senior Manager level who has experience of Clinical Supplies Management at the late stages of development of biopharmaceuticals, to be responsible for managing Kymab’s clinical supplies to outsourced partners & representatives, currently across 4 concurrent projects, with scope to increase in the future.

Key Responsibilities

  • Manage clinical supplies packaging, labelling, storage & distribution operations in-line with clinical trial requirements.
  • Work with CMO partner(s), clinical operations and clinical Site representatives to determine packaging configurations.
  • Draft then obtain review and approval of Master Label Text and label text translations.
  • Review and approval of pre & post packaging documentation.
  • Ensure documents associated with P&L and distribution operations are filed correctly with the TMF.
  • Collaborate with medical, clinical operations and CMO partner(s) to lead forecasting including drug demand & supply planning, overages, tracking of usage etc.
  • Act as point of contact for P&L/Distribution CMO partner(s) for deviations and issues arising during manufacture or distribution.
  • Act as point of contact for deviations and issues at clinical sites involving IMP.
  • In collaboration with Kymab analytical services and CMO partner(s) develop and manage storage and shelf-life strategy including oversight of expiry extensions/relabelling exercises as required.
  • Manage depot stocks, import licences, and importer of record via liaison with CMO partner(s) and clinical CRO(s).
  • Work with clinical operations, drug product development and clinical site representatives to define processes for dose preparation, labelling and delivery at site. 
  • Act as a point of contact and SME for clinical compatibility related queries from sites/CRO(s).
  • Lead definition of ancillary items required for execute dose preparation and delivery at site then identify and manage vendors to source appropriate clinical ancillary supplies including import and distribution to clinical sites.
  • Support pharmacy manual authoring and review, integrating data from compatibility & simulated administration studies.
  • Communicate progress and identify risks and issues arising to the Director, CMC Program Management & Project Leads as appropriate.

Job Requirements

Education & Experience

  • Significant experience of Clinical Supplies management (mAbs and/or biologics).
  • Proven track record of managing CMOs to ensure optimal delivery to time, cost & quality.
  • Experience in maintaining CMC documentation within a QMS and/or eTFM.

Skills & Knowledge

  • Exceptional communication, organizational skills & project management skills.
  • Excellent management skills allied with ability to control contractors and collaborators.
  • Conversant with Quality requirements of EU & US directives and ICH biologics guidelines.
  • Knowledge of cGMP/cGCP and related regulatory guidelines governing the manufacture and clinical trial use of biologics in the UK, EU & USA.

Competencies

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