Head of Process Development Senior Scientist

hace 2 semanas

Barcelona, Barcelona, España Robert Walters Spain A tiempo completo
Job Title: Head of Process Development Senior Scientist

Robert Walters Spain is seeking a highly skilled and experienced Senior Scientist to lead and direct the technical operations related to Upstream Process (USP) and Downstream Process (DSP) development for biopharmaceutical products. The successful candidate will be responsible for driving innovative strategies, overseeing process development and process characterization activities, and ensuring the scalability and efficiency of bioprocesses in line with regulatory requirements.

Key Responsibilities:
  • Develop and implement the overall strategy for USP and DSP development in alignment with Leanbio's clients objectives.
  • Lead, mentor, and develop a high-performing team of process scientists and engineers.
  • Ensure that process development and process characterization activities are aligned with industry best practices, regulatory guidelines (e.g., FDA, EMA), and Leanbio's internal standards.
  • Direct the design, optimization, and scale-up of upstream and downstream biopharmaceutical processes, including fermentation, cell culture, purification, and formulation.
  • Drive process innovation for recombinant protein and mRNA production, enhancing yield, purity, and efficiency.
  • Troubleshoot and solve complex technical challenges in USP and DSP, ensuring robust and scalable manufacturing processes.
  • Oversee technology transfer to GMP manufacturing, ensuring seamless and efficient transitions.
  • Lead the design, planning, execution, analysis of results, and closure of Process Characterization studies, ensuring data-driven decisions and strong scientific justification for process parameters.
Requirements:
  • Significant experience in chromatography techniques and bioreactor cell culture processes is essential.
  • Collaborate closely with the Analytical Development Department. Additionally, when required, with Quality Control, MSAT, and Manufacturing to ensure successful product development and commercialization.
  • Provide technical expertise and leadership in regulatory submissions and audits.
  • Maintain strong relationships with external partners and CDMOs to ensure project timelines and technical requirements are met.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunity to work with a leading CDMO company in the biopharmaceutical industry.
  • Collaborative and dynamic work environment.
  • Professional development and growth opportunities.

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