Biologics Drug Product Senior Scientist

hace 2 semanas

Barcelona, Barcelona, España Almirall A tiempo completo
About the Role

We are seeking a highly skilled Biologics Drug Product Senior Scientist to join our team at Almirall. As a key member of our research and development team, you will play a crucial role in the development of biologics drug products.

Key Responsibilities
  • Subject Matter Expert (SME) for Primary Packaging Systems and biologics
  • Subject Matter Expert (SME) for Sterile Fill-Finish manufacturing processes and technology
  • Collaborate with Formulation Development SMEs to identify optimal DP formulation in combination with Primary Packaging System
  • Collaborate with Analytics SMEs to establish specifications and methods for finished products
  • Support design and development of drug product manufacturing processes according to best practice and establish documentation needed for GMP manufacturing of drug products in collaboration with CDMOs
  • Oversee non-GMP and GMP batch manufacturing at CDMOs
  • Support regulatory filings and other interactions with Health Authorities
Requirements
  • Bachelor of Science, Master of Science or PhD in engineering, chemistry, biological science or equivalent
  • 5+ years of experience working with primary packaging, Fill-Finish production, or drug product development, as well as experience from working with CDMOs
  • Advanced knowledge within Primary Packaging System with focus on pre-filled syringes, vials, and stoppers
  • Experience in collaborating with leading vendors of Primary Packaging components
  • Experience with the interface between Primary Packaging and Device (e.g. pen systems, OBI, etc.)
  • Advanced knowledge within Sterile Fill-Finish manufacturing including processes and equipment
  • Experience within DP manufacturing of protein formulation for parenteral administration
  • Experience within process designs and Quality Risk Management
  • Experience within the field of formulation development and protein stability
  • Advanced knowledge of cGMP requirements, regulations, and guidelines
Competencies
  • Team player with a positive attitude and the ability to work effectively in matrix teams in a fast-paced environment with changing priorities and a high urgency
  • Good communication and stakeholder management skills when representing the team in cross-functional and cross-site teams and with CDMOs
  • Empowered, with the ability to plan and proactively handle multiple tasks simultaneously
  • Experienced with working in an international setting with different cultures and the ability to travel

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