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Careers - EU

Process Development Scientist

Job Title: Process Development Scientist
Location: Tredegar
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.

Main Responsibilities:

  • 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.

Regulatory/Industry Responsibilities:

General

  • 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)

Specific Qualifications:

  • 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

Behavioural Competencies:

  • Ability to manage own projects / workload, ability to work within project teams

February 21, 2018


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