CMC Biologics Analytical Senior Scientist

Mission

The Biologics Development department in Almirall is growing and we are looking for a Analytical Lead/Scientist 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 Biologics Analytical Lead, you will be an instrumental team member of the Biologics Development group. The primary roles of this position are to lead all topics related to Analytics (method development, comparability studies, etc) in CDMOs as well as driving the GMP QC activities of antibody-based molecules. We are looking for someone with hands-on experience in analytical development and QC 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

• Day-to-day oversight of analytical activities performed at partnered CDMOs and CROs according to latest industry standards and regulatory guidance.
• Contribution to set up and development of in-house/outsorced analytical activities
• Definition of DS & DP specification according to applicable regulatory guidelines
• Prepare the plan for stability studies, reference standard, comparability studies
• Prepare and/or review technical documents including method development, method validation, transfer protocols and reports.
• Authoring and review of CMC regulatory analytical submissions documents
• Work closely with Drug Substance, Drug Product and Characterization Subject Matter Experts to develop analytical, characterization and comparability strategies
• Support defining/refining required processes for analytical/characterization activities
• Experience with analytical methods for GMP manufacturing
• Understanding of the detailed requirements for analytical validation and up to date with current trends
• Might include CMC leadership activities.

Education and Experience

• Master degree or PhD in relevant scientific area or equivalent
• Experience with chromatographic and pharmacopeia methods for biologics
• Experience in establishing specifications
• Experience in preparing and reviewing relevant filing documentation for regulatory applications specially for early phase
• Experience with NBEs is preferred.

Competencies

• Knowledge of GMP, GLP, GCP, Regulatory processes, a plus.
• Strong collaboration skills and experience working with external partners
• Communication skills in English written and oral
• Analytical skills
• Prioritization and Organization skills

Values

• Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
• Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
• Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
• Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.