Senior Scientist Drug Product Development

Found in: Talent UK C2 - 2 weeks ago

Slough, United Kingdom Next-Link Full time
Primary Purpose /Regulatory Responsibilities:

Establishmentof robust fit for purpose biological drug product manufacturingprocesses
for the different development phases (FIM Ph2Ph3).
Defining and selecting drug product manufacturingprocesses and parameters for clinical
manufacture.
Build close collaboration with the ExternalDP Clinical Manufacturing Team for the
establishment ofdrug product processes and manufacturing of stability and clinicalDP
batches.
Support the development andimplementation of the DP CMC development strategy within
BCPDS.
Represent the DP development project team on theTST.
Support the definition of DP processes fordifferent types of formulation (liquid in vials
PFS orother container solid (either lyophilized or spray dried) and anyother more
innovating formulation addressing parenteralroute of administration or other requirements
forclinical development and future commercial manufacture.
Provide all appropriate support to drug product process developmentactivities (eg filter
selection and sizing target fillvolume assessment compatibility assessments clinical
blinding etc) as required for clinical development.
Provide support to ensure timely delivery of stability and clinicalDP batches.
Provide support to ensure the validation ofcommercial DP processes for late stage
projects.
Ensure products are manufactured in accordancewith quality system cGMP and
latest regulatoryrequirements.
Preparation of protocols and reportsexecution of studies in relation to drug product
development activities.
Ensure capturing criticalprocess data and allow appropriate analysis ofprocesses.
Ensure appropriate batch record review toensure capturing critical process data and allow appropriateanalysis of processes.
Provide support in the completionof the relevant sections of the Product Specification File and CMCregulatory submissions and regulatory briefing documents andensure
appropriate response to questions fromauthorities.
Provide support in defining the IMPpreparation process in clinical trials.
Provide supportin investigations of deviations and complaints related to DPquality.
Ensure efficient knowledge transfer from latephase development to LCM for validated DP processes.

Requirements

Experience:


Minimum 3 years experience in sterile drug product developmentand/or manufacturing within the pharmaceutical industry isrequired. Experience within the biopharmaceutical
industry is an advantage
Good knowledge and technicalexperience in parenteral liquid drug products development and cGMPmanufacturing under aspetic conditions (such as vial Cratridge andprefilled syringe filling) would be required.
Goodtechnical knowledge of sterile DP development covering DPcomponents process transfer scale and optimization. Good knowledgeof cGMP.
An understanding of the issues and challengesof product development at phase 1 is an advantage
Knowledge in primary packaging and regulatory requirements is anadvantage




- Minimum 3 years experience in sterlie drug product developmentand/or manufacturing within the pharmaceutical industry isrequired. Expericence within the biopharmaceutical industry is anadvantage -Good knowledge and technical experience in parenteralliquid drug product development and cGMP manufacturing underaspetic conditions (such as vial, cratridge and pre-filled syringefilling) would be required. - Good technical knowledge of sterileDP development covering DP components, process transfer, scale andoptimization. Good knowledge of cGMP. -An understanding of theissues and challenges of product development at phase 1 is anadvantage -Knowledge in primary packaging and regulatoryrequirements is an advantage

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