Manager in Process Development

Position summary

Responsible for project management in technology transfers, development, optimization, characterization and automation of cell and gene therapy investigational medicinal products.  Directly reports to Quality Control & Process Development Manager.

Key Activities and Responsibilities:

  • Project management role in the technology transfer of the new products
  • Project management of process development or analytical development projects:
    • Development of new products and technologies from preclinical through pilot plant and manufacturing scale.
    • Manufacturing process automation
    • Manufacturing process validation
    • Manufacturing process optimization or troubleshooting
    • Analytical methods development, optimization, troubleshooting
    • Analytical methods qualification
  • Participates in preparation and revision of standard operating procedures (SOP) of manufacturing and quality control processes.
  • Participates in quality assurance processes:
  • o Internal or external audits
  • o Regular controls of manufacturing processes and processes of quality control
  • o CAPA investigation
  • o Change requests
  • Provides training for QC and manufacturing associates
  • Participates in preparation of documents for regulatory authorities
  • Represents departmental activities as needed, including project teams, presentations at internal and external meetings, audits and business related activities with third parties.

Competences, Skills and Qualification

  • University education, Ph.D. in biology, pharmacy or biochemistry
  • Upper Intermediate or preferably advanced knowledge of English with solid communications skills
  • Proven experience with project management
  • Proven experience and knowledge of cell biology/molecular biology/biochemistry related laboratory techniques
  • Advantage is previous experience from biotech or pharmaceutical manufacturing company and knowledge of GMP
  • Advantage is knowledge of cell culture techniques, gene therapy, flow cytometry, PCR
  • Conscientiousness, reliability, and time flexibility
  • Medically fit
  • Personal integrity (a clean criminal records certificate)
  • Adequate knowledge of software and computer tools

Location

  • Jankovcova 1518/2, 170 00 Praha 7, Česká republika

Position summary

Responsible for project management in technology transfers, development, optimization, characterization and automation of cell and gene therapy investigational medicinal products.  Directly reports to Quality Control & Process Development Manager.

Key Activities and Responsibilities:

  • Project management role in the technology transfer of the new products
  • Project management of process development or analytical development projects:
    • Development of new products and technologies from preclinical through pilot plant and manufacturing scale.
    • Manufacturing process automation
    • Manufacturing process validation
    • Manufacturing process optimization or troubleshooting
    • Analytical methods development, optimization, troubleshooting
    • Analytical methods qualification
  • Participates in preparation and revision of standard operating procedures (SOP) of manufacturing and quality control processes.
  • Participates in quality assurance processes:
  • o Internal or external audits
  • o Regular controls of manufacturing processes and processes of quality control
  • o CAPA investigation
  • o Change requests
  • Provides training for QC and manufacturing associates
  • Participates in preparation of documents for regulatory authorities
  • Represents departmental activities as needed, including project teams, presentations at internal and external meetings, audits and business related activities with third parties.

Competences, Skills and Qualification

  • University education, Ph.D. in biology, pharmacy or biochemistry
  • Upper Intermediate or preferably advanced knowledge of English with solid communications skills
  • Proven experience with project management
  • Proven experience and knowledge of cell biology/molecular biology/biochemistry related laboratory techniques
  • Advantage is previous experience from biotech or pharmaceutical manufacturing company and knowledge of GMP
  • Advantage is knowledge of cell culture techniques, gene therapy, flow cytometry, PCR
  • Conscientiousness, reliability, and time flexibility
  • Medically fit
  • Personal integrity (a clean criminal records certificate)
  • Adequate knowledge of software and computer tools

Location

  • Jankovcova 1518/2, 170 00 Praha 7, Česká republika