Senior Principal Scientist, Drug Product Design

21 Jun 2021
05 Jul 2021
Full Time
Contract Type

Senior Principal Scientist, Drug Product Design

We are seeking a senior principal scientist to lead design, development and commerlisation of adult and paediatric dosage forms. It will be your job to plan, prioritise and critique the work within a matrix team environment. You will apply quality by design principles to experiments and solve technical problems for small molecule oral liquid and solid oral dosage forms. You will apply knowledge across a broad range of manufacturing techniques to influence the Pfizer development strategy. You will report and communicate findings clearly within the department and to other Pharm Sciences lines and commercial manufacturing.


Major Duties:

  • To be the project lead for the formulation and process development of commercialisable solid and liquid oral dosage forms for New Chemical Entities (NCE's).
  • To design high quality scientific experimentation to further the formulation and process development of solid oral dosage forms for novel drug candidates.
  • To lead the definition of processes for solid oral dosage forms for clinical supplies and/or commercial drug product.
  • To work in a matrix team environment, both internal and external to Pfizer, leading the development of solid oral dosage forms.
  • Team building by leading a project team across Biopharm, formulation and process design and material science to deliver quality clinical or commercial drug products to agreed milestones
  • To assess the chemical and physical stability of formulations in collaboration with analytical departments and to identify the root cause of potential stability, manufacturability and performance issues.
  • Apply appropriate project management skills to all projects.
  • Generate innovative ideas and concepts for developments in mid and long term
  • Design and undertake high quality scientific experimentation to further the formulation and process development of dosage forms for novel drug candidates or product enhancement projects, which may include formulation and analytical/characterisation activities to derive appropriate data.
  • Take responsibility for writing up experiments in line with departmental and site guidelines and authoring technical reports.
  • Contribute to the drafting of the relevant sections of the quality modules of regulatory documentation (IND/CTX and NDA/MAA).
  • Interpret scientific data to derive clear conclusions and provide direction for future work. Provide technical support to the Pharm Sciences multidisciplinary team to facilitate and influence the development of quality drug products.
  • Develop and maintain a contemporary in-depth understanding of the science, technology and regulation of pharmaceutical dosage forms and apply this knowledge to development of assigned drug candidates.
  • Communicate effectively to line managers and the wider development team and present data at departmental technical governance meetings.
  • Share lessons and experience with colleagues and look for opportunities to develop novel technologies and processes to advance science of characterisation, formulation and process development of all dosage forms.
  • Ensure safe working practices aremaintained both in own and others work.
  • Ensure efficient staff development for continuous enhancement of technical skills, scientific knowledge and personal growth


Skills, Qualifications and Experience

  • PhD in a relevant discipline or equivalent experience - Honours degree in Pharmacy, Pharmaceutical Sciences, Analytical Chemistry, Chemistry, Physical Organic Chemistry, Chemical Engineering or a related discipline.
  • Significant experience in a pharmaceutical or related environment.
  • Practical experience in the development of drug products
  • Will have some team leadership experience
  • Demonstrable track record of innovation in drug product development
  • Track record of a highly rigorous scientific approach to problem solving
  • Effective collaboration and leader / interpersonal behaviours at departmental / inter-departmental / cross-site level
  • Flexible resourcing / project prioritisation in a dynamic portfolio environment
  • Relevant external networks e.g. interfaces with industry focus groups, academia, vendors
  • A thorough understanding of drug product development .
  • Knowledge of the current regulatory frame work for the commcialisation of different dosage forms such as Quality by Design
  • Understanding of the requirements of Good Manufacturing Practice (GMP) for the manufacture of clinical supplies
  • Deliver reports that can be included in regulatory dossiers
  • High level of practical experience.