Specialist in Process Development
Responsible for 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
- Participates in process development of new products and technologies from preclinical through pilot plant and manufacturing scale.
- Participates in manufacturing and quality control automation projects performed within Process Development department
- Optimizes existing process and technologies for the purpose of creating more efficient and compliant manufacturing and operational processes. Responsible for planning, performance and proper documentation of laboratory experiments within optimization, development, characterization, stability or validation studies.
- 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.
- If needed, exceptionally participates in GMP manufacturing of IMP
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 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
- Driving licence