Biologics Drug Substance Senior Scientist

Mission

The Biologics Development department in Almirall is growing and we are looking for a Drug Substance Scientist/Manager that is going to help us bring the best innovative biopharmaceuticals to patients and will join the team in our R&D center in Barcelona!

Our biologics pipeline is growing, and we need your competences to secure our end goals are meet.

As our Drug Substance Specialist, you will be an instrumental team member of the Biologics Development group. The primary roles of this position are to lead drug substance development and optimization studies in CDMOs as well as driving the GMP manufacturing of antibody-based molecules. We are looking for someone with hands-on experience in Upstream, Downstream, or general drug substance knowledge and that is willing to grow with the company.

You will work in close collaboration with colleagues across the organization, as a member in our multidisciplinary project teams and in close contact with our network of global Contract Development Manufacturing Organizations (CDMOs).

Tasks and Responsabilities

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.

Competencies

• 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

Values

• Care
• Courage
• Innovation
• Simplicity