Biologics Drug Substance Senior Scientist

hace 4 días

Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

Mission

Lead the development and oversight of Drug Substance (DS) activities, with a strong focus on Downstream Processing (DSP) and strategic CMC leadership across biologics programs. Ensure alignment with regulatory standards and internal quality systems throughout the product lifecycle.

Key Responsibilities

  • Provide technical leadership in DSP strategy, development and optimization for biologics.

  • Oversee external partnerships for DS manufacturing, ensuring compliance with GLP/GMP and Regulatory requirements.

  • Lead CMC strategy and execution from early development through to regulatory filing.

  • Review and approve technical documentation, deviations, and change controls.

  • Drive cross-functional collaboration with Clinical Operations, Regulatory Affairs, and Quality Assurance.

  • Support regulatory submissions with robust CMC documentation and risk assessments.

  • Mentor junior scientists and contribute to talent development within the Biologics Development team.

Profile Requirements

  • Advanced degree in Biotechnology, Biochemistry, Pharmacy, or related field.

  • Minimum 5 years of experience in biologics DS development, with proven DSP expertise.

  • Demonstrated CMC leadership across multiple phases of development.

  • Fluent in English.

  • Strong project management and communication skills.

  • 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

Why work with Almirall?

We are a people-centric company where employees are at their best, patients and customer are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all.

Additionally, for the 17th year in a row, we have been certified as Top Employer Spain, and also Top Employer Germany for the first time.

This strengthens our commitment to create a unique work environment that helps our employees to develop their skills to fullest and grow both professionally and as individuals.

We are delighted to have a great team that is proactive, innovative, and eager to transform the world of people with skin conditions.

We are proud of each one of our employees, their development, and growth: they are the success of the company.

Our purpose

"Transform the patients' world by helping them realize their hopes & dreams for a healthy life".

Our 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.

At Almirall, it's all about people

#wearealmirall

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