Process Development Scientist
Job Title: Process Development Scientist
Department: Technical Management
Reporting to: Senior Process Development Scientist
Responsible for (staff): N/A
General Purpose of Role:
- The 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 external sending sites, 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.
- To comply with Company Policies, including HSE and environmental standards for the handling of potent formulation down to OELs of 0.01μg/m3.
- To identify self-development needs for future performance.
- To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.
- The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.
GMP Requirements Hierarchy
- GMP Skill Level 1 is essential for this role (further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001)
- 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 in 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 pharma technical transfer and process development
- Good communication, client facing experience
- Ability to manage own projects / workload, ability to work within project teams
February 21, 2018