Process Development Scientist
Job Title: Process Development Scientist
Department: CMF Technical
Reporting to: Senior Manager CMF
Responsible for (staff): None
General Purpose of Role:
- This role is responsible for all aspects of their assigned process/equipment train, including client and auditor facing meetings. The role requires the individual to lead complex FD projects for assigned process, produce GMP documents and lead deviation investigations and advice on CAPEX or CI improvements.
- Lead technical transfer and scale up development of new projects coming from Formulation Development (FD) and client groups into the operations group.
- Able to act as SME for their assigned process/equipment train to support all internal and external needs.
- Lead complex deviation investigations to determine root cause and support CAPA implementation.
- Advise and support CAPEX and/or improvement activities in this area.
- Liaise with all functions to ensure production schedules are adhered to 100% of the time and where this is not possible root causes are captured and actioned.
- To communicate effectively with internal and external customers and participate with them in problem solving and continuous improvement activities.
- Responsible for the reviewing of manufacturing batch records for technical transfer and continuous improvement projects in accordance with cGMP practices.
- Responsible for progressing and assisting in the technical aspects of process validation exercises.
- To assist in training of FD and Manufacturing personnel where required and promoting best practices for technical transfer and continuous improvement.
- To observe safe working practices in handling of materials and when conducting manual handling activities.
- Degree educated in a suitable scientific discipline (e.g. chemistry, pharmacy, microbiology, engineering). A higher degree in pharmaceutical processes/chemical engineering is advantageous.
Previous Work Experience:
- Significant experience (equivalent to 5+ years) within a similar level role.
- Pharmaceutical/Chemical/Regulated processing environment, ideally OSD (Oral Solid Dosage) and potent molecules.
- Technical Transfer and scale up experience.
Specific Knowledge / Skills Competence:
- Knowledge of cGMP/Validation/FDA and Japanese market
April 1, 2016