Scientist / Senior Scientist – Extractables & Leachables (Drug Product Development)

We are seeking a motivated and detail-oriented Extractables & Leachables (E&L) Scientist to join our Drug Product Development team. E&L are chemical compounds that can migrate into the drug product from single use systems and/or primary packaging containers (vials or syringes) during manufacturing and long-term storage, and potentially influence its composition, stability and safety.

In this role, you will support the development of liquid and lyophilized biopharmaceutical products by designing E&L studies in close collaboration with our testing partners to evaluate the compatibility of primary packaging systems, process contact materials, and delivery devices.

You will collaborate cross-functionally with formulation, analytical development, quality, regulatory, and external testing partners to ensure our drug products meet the highest safety and compliance standards.

Join a collaborative, science-driven environment where you'll have the opportunity to make a direct impact on the development of biosimilars; life-changing biologics that improve patient access and outcomes. This role offers exposure to multiple facets of drug product development, along with strong potential for professional growth and career advancement.

Key Responsibilities:

• Design, plan, and oversee extractables and leachables studies for primary packaging systems, process contact materials, and delivery devices used in liquid and lyophilized drug products.
• Develop study protocols in line with ICH, USP <1663>/<1664>, and regulatory expectations.
• Partner with internal analytical scientists and external laboratories to execute and interpret E&L studies.
• Provide scientific expertise on material compatibility and risk assessment throughout product lifecycle stages.
• Author technical reports and contribute to regulatory submissions (IND, BLA, MAA).
• Stay up to date with evolving E&L regulatory guidelines, industry trends, and best practices.

Qualifications:

• MSc or PhD in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related fields.
• 2–5+ years of relevant industry experience in extractables and leachables, analytical sciences, or drug product development (experience level flexible depending on role level).
• Hands-on or oversight experience with E&L study design, and data interpretation.
• Strong understanding of relevant regulatory guidance (ICH, USP, EMA, FDA).
• Excellent communication skills with the ability to work in a multidisciplinary and collaborative environment.

What We Offer:

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be a part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration and inclusion.
• Positive, flexible, and innovative work environment.
• Support for personal growth and internal career development.
• Company social events and milestone celebrations.
• Excellent in-house canteen and coffee house.
• Exercise and wellbeing support for full-time employees.
• On-site shower facility.
• Transportation grant towards eco-friendly modes of travel for full-time employees.
• Internet at home for full-time employees.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.