Reference
PRCMC
Type
Permanent
Location
Home-Based
Salary
£75,000 - £90,000 Per Annum + Excellent Package
Category
Research & Development
Sector
Pharmaceuticals / Biotechnology / FMCG

About the role

You’ll be responsible for scientific/technical leadership and oversight of outsourced Drug Substance & Drug
Product late-stage/commercial CMC development, manufacture, process characterisation & validation in support
of multiple clinical development programmes to eventual commercialisation. This will be delivered
through your effective leadership of CDMOs and internal resources. You will serve as a subject matter expert
across CMC activities and author/reviewer of relevant sections of CMC documentation in support of CTA/INDs
and BLA/MAA submissions and represent CMC function on the Core Project Teams, proactively identifying gaps
and risks and working with the team to develop mitigation plans

Responsibilities

  • Responsible for successful delivery of outsourced Drug Substance and Drug Product late stage/commercial manufacturing process development, characterisation and validation for several
    clinical programmes
  • Responsible for clinical supply strategies aligned with Clinical Development Plans
  • Oversee the development and implementation of stage appropriate analytical methods and stability
    studies
  • Lead and oversee appropriate critical process parameter studies for the drug substance and drug product
    preparing for registration and validation batches. Responsible for planning, documenting, and overseeing
    the execution of all relevant PPQ/PPV protocols
  • Review and approval of CDMOs GMP documentation, i.e. specifications, protocols and batch records
    Serve as a subject matter expert and author and/or review relevant sections of CMC documentation in
    support of regulatory submissions, amendments, and scientific briefing documents
  • Maintain in-depth knowledge of manufacturing processes, and quality controls following regulatory
    guidance and QbD principles in accordance with the cGMP requirements to ensure on-time delivery of
    the clinical materials
  • Establish and maintain CMC budget for assigned projects

Experience Required

  • Proven track-record of leading late-stage/commercial CMC development for monoclonal antibodies or
    related therapeutic proteins, process validation, and manufacturing in support of marketing applications
    and commercialisation
  • Experience in clinical and commercial phase biotech environment would be advantageous
  • Abreast of cGMP and related regulatory guidelines governing the manufacture of biologics in the UK, EU
    & USA is desired
  • Experience as the primary author of relevant sections of BLAs or MAAs
  • Strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change
  • Excellent verbal and written communication skills both through face to face and remote interactions
  • Ability to effectively work independently in a team environment and substantial experience with managing external CDMOs to meet timelines within the approved budgets
  • Recognises the importance of developing and guiding others and encourages a collaborative approach to
    learning
  • Enjoys working under pressure and meeting deadlines
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