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Operations Manager - Biologics

Employer
CK Group
Location
UK
Salary
Competitive
Closing date
15 Sep 2021

View more

Sector
Engineering
Contract Type
Permanent
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Job Details

CK Group are recruiting for an Operations Manager with experience within biologics/ biotech or pharmaceutical operations, to join a biotechnology company, to be based at their growing site in Stevenage on a permanent basis.

The Company:

A clinical-stage immuno-oncology company, that have recently embarked on establishing a new cGMP manufacturing operation, to provide manufacturing capacity for Phase 1 and Phase 2 operations.

The Role:

To support all site functions with regards to facilities administration, equipment/ asset management, management of IT providers and lead site health and safety matters. An exciting opportunity to join the team at an early stage, to deliver life saving therapies to cancer patients across a broad class of indications.

Responsibilities:
  • Manage the GMP and non-GMP facilities at to provide a safe and productive working environment for all staff, contractors and visitors
  • Act as the primary interface with facilities and engineering teams
  • Lead facility expansion and improvement projects and act as the primary interface with landlords and third parties involved in build programs
  • Manage asset management (equipment metrology, scheduling and execution, planned maintenance and repair with suppliers)
  • Manage IT service providers for software and hardware needs for both GMP and non-GMP operations
  • Act as a technical expert for cleanroom and laboratory design
  • Oversee facilities expenses and reporting for rent, services, insurance and energy for all building to agreed budgets
  • Act as the Health and Safety representative for the company


Your Background:
  • BSc degree in a biological sciences or equivalent and wealth of experience within pharmaceutical, biotech, or biologics operations and facilities management (7 - 8 years+)
  • Knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU and ICH standards
  • Experience and involvement in external regulatory inspections an advantage
  • Experience in dealing with Health and Safety issues
  • Ability to negotiate and build collaboration with third parties and service providers


Apply:

Entitlement to work in the UK is essential.

For more information or to apply for this, please contact Naynesh Mistry on 01246 457703 or email nmistry@ckgroup.co.uk. Please quote reference 51584.
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