Meet AM-Biotech-Consulting at Bioproduction Congress, Tours, Sept 25th and 26th

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Why AM-Biotech Consulting

Marielle Anger, PhD

CMC Biotech expert consultant

After working several years in different companies including start-ups, biotech and big pharma, I decided to become a CMC expert Consultant in biotechnology  (specializing in recombinant proteins and cell & gene therapy). This role allows to offer my expertise across a range of therapeutic areas. 

Having personally faced to the challenges of my daughter’s battle with cancer, I am deeply motivated to contribute my knowledge to help companies for the development of innovative and dedicated therapies that treat cancer with fewer side effects. 

Profile

25 years of experience accross various companies 

  • Biotech, Start-up, Pharma
  • Over 15 years as Biotechnology CMC expert
  • Senior project manager
  • Senior GMP manufacturing manager

Senior project manager

  • Multi-project management for recombinant proteins, including mAbs, bispecifics, and transgenic products (from cell line development to drug product manufacturing)
  • Project manager of CAR-T cell projects (process industrialization and clinical manufacturing)

CDMO project manager

  • Implementation of manufacturing services. 
  • Preparation of templates : quotations, pricing lists, Master Service Agreement (MSA), and quality agreeements
  • Management of client relationships and coordination with technical teams

Out-sourcing manager

  • Preparation of Requests for proposal (RFP)
  • CRO/CDMO selection, negotiation, and management
  • Preparation of User Requirement Specifications (URS) and batch record review 
  • Development of strategic partnerships 

Technical expertise

  • Mammalian cell culture, transgenic development and bioproduction
  • Microbial fermentation 
  • CAR-T cells development and manufacturing
  • Project coordination : optimization, industrialization, tech transfer, out-sourcing and bioproduction
  • Proven success in the development of multiple biopharmaceuticals products

Document writing and review

  • Preparation of CMC sections for IMPD, IND, and Investigation Brochure…
  • Writing of protocol and report templates for development activities
  • Preparation of batch records for GMP manufacturing
  • Writing of tech transfer protocols and reports 
  • Due diligence evaluations (in and out) 

Non-GMP and GMP facility set-up

  • Set-up of a non-GMP Biotech area (Ireland)
  • Coordination of non GMP and GMP facility unit implementation (10 000m2) within Project engineering management, including meetings, planning, and budget oversight (France)

Team manager 

  • Managed various teams thoughtout my career, including:

    • Research and Scientific teams  
    • Technical teams (cell culture, transfection, purification…)
    • Experts (project managers, scientific experts, viral safety experts, cell therapy experts)
    • GMP teams (drug substance, drug product, supply chain, maintenance)

Training

  • Biotech trainer
  • Contribution to the setup of E-learning Biotech training modules

 

Values

Passionate and fully invested in the development of new innovative therapies through quality, leadership and kindness.

Passion

The enthusiasm and desire to offer solution that help, improve and positively impact patient needs.

Collaboration

Development and improvement of new products through synergies and professional skills.

Excellence

Because your project is unique, the development will be performed following the rules of the art and quality requirements.

Mindset

Drive your project to success in transparency through application of strong expertise and mindset.