Biologics Drug Substance Senior Scientist

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Biologics Drug Substance Senior ScientistMission Your job and key responsibilities in Biologics Development will involve:
Subject Matter Expert (SME) for Upstream or Downstream process development, scale up and manufacturing of Biologics. SME for MCB/WCB manufacturing and storage. Work in close collaboration with our Analytics SMEs to stablish specifications and methods for BDS. Support design and development of drug substance manufacturing processes according to best practice and establish documentation needed for GMP manufacturing of drug substance in collaboration with the CDMOs. Oversee non GMP and GMP batch manufacturing at CDMOs. Supporting regulatory filings and other interactions with Health Authorities. CMC leadership of early development projects. This position is a great development opportunity where you will be part of defining future configurations and manufacturing strategies of biologics within Almirall and work in an exciting interphase with various internal and external stakeholders. You will have the chance to lead full CMC projects as part of your development.
Education and Experience You hold a Bachelor of Science, Master of Science or PhD in engineering, chemistry, biotechnology, pharmacy, biological science or equal. In addition, you bring 5+ years of experience working with drug substance development, as well as experience from working with CDMOs.
Specific Knowledge Advance knowledge in DS upstream or downstream process development. Knowledge of cell banking manufacturing and storage. Experience in collaborating with leading vendors for Drug Substance development. Experience within DS manufacturing of biopharmaceuticals. Knowledge of analytical techniques for biological products. Knowledge of cGMP requirements, regulations, and guidelines. Candidates not fulfilling not all the listed qualifications are still encouraged to apply, as the position can be adjusted according to qualifications and development is part of the career path in Almirall.
A 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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