Reference
HQCSTEV
Type
Permanent
Location
Stevenage
Salary
£60k - £90k per annum
Category
Research & Development
Sector
Pharmaceuticals / Biotechnology / FMCG

ABOUT THIS ROLE

Northreach are partnering with an exciting biotech company specialising in developing of engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system.

 

The initial focus will be on setting up the site for clinical production. There is strong career growth potential with the possible addition of other manufacturing sites and the prospect of delivering commercial products at a later date. We are looking for a talented and highly motivated individual with a strong background in Quality Control and a good understanding of cell (and gene) therapy production and analytics. They will have a good understanding of the integration of QC into a manufacturing environment.

KEY RESPONSIBILITIES

  • QC team build-out and development.
  • QC staff training and performance monitoring to ensure operations are compliant with the requirements of GMP
  • QC laboratory set-up and operations, incl. qualification, servicing, and calibration of QC equipment as appropriate
  • Management of all QC analytical activities at Stevenage including environmental monitoring and microbiology
  • Overseeing assay transfers (receiving site) and ensuring compliance with established procedures.
  • Manage documentation of the group, incl. reviewing plans, specifications, reports, operating procedures, and test methods, as well as author and/or contribute to technical reports
  • Development of specifications for and approval/rejection of starting materials, packaging materials, intermediates and finished products
  • Establish and monitor the stability of the products
  • Supervision of the control of the reference and/or retention samples of materials and products
  • Monitor and trend in-process and final product analytical results to support quality improvements and risk management
  • Support and/or lead manufacturing investigations and contribute to root cause analysis and CAPA planning
  • Identify, select, approve, and manage contract analytical laboratories and service providers involved in finished product testing
  • Close collaboration with Production, QA and other key departments and Cell and Gene Therapy Catapult functions to ensure cross-functional alignment during site set-up and clinical production
  • Acting as Head of QC named on the manufacturing license defined in EU/UK GMP
  • Review and approve QC related batch testing records prior to QA review and QP certification
  • Champion a continuous improvement environment, working collaboratively with other key functions, CGT Catapult and other collaborators on site.

THE IDEAL CANDIDATE

EXPERIENCE WE ARE LOOKING FOR

  • A minimum of 10 years’ experience operating within a QC and/or Analytical Development environment
  • Resource planning, recruitment, and development of staff
  • Working knowledge of clinical manufacturing of cell (and gene) therapies
  • Strong knowledge of GxP regulations and how to apply them to clinical and commercial products
  • Understanding and experience in managing QC activities in Technology Transfer programs
  • Managing various stakeholders’ expectations and set expectations for timely delivery, incl. milestones and deadlines
  • Demonstrated ability to work across departments to achieve functional goals

 

TECHNICAL SKILLS REQUIRED

  • Degree, MSc or PhD in Life Sciences or related field
  • Previous experience of setting up and/or managing QC operations for clinical trials
  • Broad expertise in immunology and cell-based assays as well as microbiological safety testing
  • Relevant GxP experience
  • Recruiting, leading, and developing teams to tight deadlines
  • Proven track record in Quality Control
  • Strong communication and stakeholder management skills
  • Ability to operate in a changing / fast-paced environment
  • Confident and pragmatic problem-solving ability
  • Excellent verbal and written communication skills in English

 

DESIRABLES

  • Significant working experience of leading a QC department in a clinical and/or commercial cell and gene therapy manufacturing environment
  • Experience using QbD principles and tools e.g., DOE to develop analytical methods

 

PERSONAL QUALITIES

  • Excellent team working and networking skills with experience of interacting effectively across interfaces of discipline, culture, and expertise
  • Desire to work with integrity and act as an ambassador for the company and the wider business

 

BENEFITS

  • Holidays: 25 days per year
  • Life Assurance: 4 x base salary
  • Group Personal Pension: Auto enrolled at 4% employer contribution, 4% employee contribution
  • Private Medical Insurance for your whole family
  • Annual Bonus

 

PERKS

  • Fantastic collaborative environment at Translation & Innovation Hub o Click here for Virtual Tour
  • $156 Million Investment including brand new lab equipment, innovative methods, and exposure to cutting edge technology
  • Flexible working
  • Fast paced and progressive company looking for future leaders and innovators
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