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Senior Formulation Scientist

Job Title: Senior Formulation Scientist
Location: Tredegar
Department: CMF
Reporting to: Associate Director of CMF
Responsible for (staff): N/A

General Purpose of Role:

  • This role is part of the CMF Technical Team. As a Senior Formulation Scientist in early and late stage Drug Product Development you would be responsible for developing and implementing robust processes for oral dosage forms. The role requires the individual to lead complex development, process optimisation and scale up activities, produce technical documents, including GMP documents, and lead deviation investigations and advice on CAPEX or Improvement Projects.

Main Responsibilities:

  • Responsible for all technical aspects of their assigned projects.
  • Able to act as SME for their assigned process/equipment train to support all internal and external needs including client and auditor facing meetings.
  • Generation of technical documentation for CMF projects, including excipient gap analysis, process gap analysis, protocols, FMEA, master batch records, and technical reports.
  • Conduct scientific experimentation using statistical tools and processing experience
  • Analysis, trending and evaluation of technical data using statistical tools where required with recommendations to further experimentation.
  • Support the identification and implementation of improvements through use of Lean Six Sigma tools and techniques.
  • 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

Specific Qualifications:

  • Degree in a suitable scientific discipline (e.g. chemistry, pharmacy, microbiology, engineering)
  • Ideally post graduate qualification in a suitable scientific discipline

Previous Work Experience:

  • Significant experience in Pharmaceutical development of OSD
  • Significant experience Pharmaceutical development of OSD.
  • Experience of statistical and DOE tools e.g. Minitab

Specific Knowledge / Skills Competence:

  • Knowledge of pharmaceutical development, scale up and commercial manufacturing
  • DOE and statistical analysis
  • Knowledge of cGMP requirements

Behavioural Competencies:

  • Excellent written and verbal communication skills.
  • Attention to detail and ability to analyse complex technical data
  • Communicate effectively with internal and external customers
  • Ability to work on own initiative and as part of a team. Ability to ensure all KPIs, targets and any other department/client deadlines are met
  • Identification and implementation of improvements through use of Lean Six Sigma tools and techniques
Posted on Categories EU, EU Tredegar, Vacancies

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PRE-CLINICAL
PHASE I
PHASE II
PHASE III
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PRE CLINICAL

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  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI Phase 1
  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase I packaging and labelling
  • Storage and distribution

PHASE 2

PCI Phase 2
  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase II packaging and labelling
  • Storage and distribution

PHASE 3

PCI Phase 3
  • Comparator Sourcing
  • Scale Up Studies
  • Phase III Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase III packaging and labelling
  • Analytical testing and stability services
  • Storage and distribution

COMMERCIAL

PCI Commercial Phase
  • Scale up for commercial supply
  • Commercial product manufacture
  • Commercial packaging and labelling
  • Validation services
  • Analytical testing and stability services
  • Product release to market
  • Storage and distribution

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