Cpl in partnership with our client Pfizer are seeking a Process Development Scientist to join the team for an 11 month fixed term contingent contract at their state of the art plant in Dublin, Grange Castle. this is an onsite role.
Job title: Process Development Scientist (Drug Substance)
Department: Process Development, Manufacturing Science and Technology (MSAT), Grange Castle
Job description:
Drug Substance Process Development Scientist will be responsible for developing and implementing strategic goals and initiatives related to real-time process and rapid analytical tools, with a focus on enabling quick meaningful insights into new and second-generation drug substance processes.
The successful candidate will be responsible for developing and implementing rapid 'in-process analytical' methods for real-time and near-real time process analytical technology, with an emphasis on digitization of scientific workflows to enable rapid turn-around from bench to decision-making. The role provides unique opportunity to work across large molecule portfolio products from proteins, to bioconjugated and mRNA vaccines.
You will support a broader commercial biotherapeutic team in completing regulatory submissions and ensuring commercial supply for the Pfizer portfolio across a range of biotherapeutic modalities. This includes collaborating with representatives from Biotherapeutics Pharm Sci, Vaccines R&D, manufacturing sites, quality, procurement, supply chain, Regulatory CMC, etc.
Responsibilities:
• Develop and implement digital workflows to enable rapid analyses for in-process analytics and process development.
• Utilise range of analytical tools (such as but not limited to HPLC, LC-MS and DSC) and apply them to process development milestones, to lead complex projects across the division
• Collaborate with the In-Process Analytical and Process Analytical Technology teams within the drug substance department to build high-throughput measurement capability and develop real-time analytics in close collaboration with GTE Manufacturing Intelligence and GTE Analytical Technologies, leveraging digital tools and technologies.
• Develop mechanisms for monitoring project progress and intervene and problem-solve with project managers, line managers, and external departments.
• Assess project issues and develop resolutions to meet productivity, quality, and client satisfaction goals, leveraging digital solutions where applicable.
• Anticipate and troubleshoot roadblocks in complex project environments, leveraging digital tools and technologies to overcome challenges and achieve targets for the division.
Qualifications:
• Preferred 2+ years of experience with a B.Sc./M.Sc in the biopharmaceutical industry or a PhD in related field.
• Education and technical experience should include chemistry, protein biochemistry, glyco-biology, analytical chromatography, Automation technologies, spectroscopy, microbiology, molecular biology, cell- and immunology-based bioassays and drug stability studies.
• Experience in all aspects of process development and product characterisation programs for proteins and glyco-conjugate vaccines.
• Experience in method qualification and validation.
• Proficient with the use of a variety of problem-solving, risk analysis and statistical tools.
• Experienced in Regulatory dossier compilation and developing CMC responses.
• Strong working knowledge of the Quality/GMP/ICH/compliance systems of the biopharmaceutical industry.
Candidates with some of the outlined requirements are encouraged to apply. The position will provide opportunities to lead complex projects across departments. Your ability to develop and manage plans will facilitate achieving ambitions objectives and solving business challenges.