Senior Scientist Drug Product Development

3 weeks ago

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

• Establishment of robust, fit for purpose biological drug product manufacturing processes
for the different development phases (FIM, Ph2, Ph3).
• Defining and selecting drug product manufacturing processes and parameters for clinical
manufacture.
• Build close collaboration with the External DP Clinical Manufacturing Team for the
establishment of drug product processes and manufacturing of stability and clinical DP
batches.
• Support the development and implementation of the DP CMC development strategy within
BCPDS.
• Represent the DP development project team on the TST.
Support the definition of DP processes for different types of formulation (liquid in vials,
PFS or other container, solid (either lyophilized or spray dried), and any other more
innovating formulation addressing parenteral route of administration or other requirements
for clinical development and future commercial manufacture.
• Provide all appropriate support to drug product process development activities (eg filter
selection and sizing, target fill volume assessment, compatibility assessments, clinical
blinding, etc) as required for clinical development.
• Provide support to ensure timely delivery of stability and clinical DP batches.
• Provide support to ensure the validation of commercial DP processes for late stage
projects.
• Ensure products are manufactured in accordance with quality system, cGMP and
latest regulatory requirements.
• Preparation of protocols and reports, execution of studies in relation to drug product
development activities.
• Ensure capturing critical process data and allow appropriate analysis of processes.
• Ensure appropriate batch record review to ensure capturing critical process data and allow appropriate analysis of processes.
• Provide support in the completion of the relevant sections of the Product Specification File and CMC regulatory submissions and regulatory briefing documents and ensure
appropriate response to questions from authorities.
• Provide support in defining the IMP preparation process in clinical trials.
• Provide support in investigations of deviations and complaints related to DP quality.
• Ensure efficient knowledge transfer from late phase development to LCM for validated DP processes.

Requirements

Experience:


- Minimum 3 years experience in sterile drug product development and/or manufacturing within the pharmaceutical industry is required. Experience within the biopharmaceutical
industry is an advantage
-Good knowledge and technical experience in parenteral liquid drug products development and cGMP manufacturing under aspetic conditions (such as vial, Cratridge and pre-filled syringe filling) would be required.
- Good technical knowledge of sterile DP development covering DP components, process transfer, scale and optimization. Good knowledge of cGMP.
-An understanding of the issues and challenges of product development at phase 1 is an advantage
-Knowledge in primary packaging and regulatory requirements is an advantage

 



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