Combination Product Lead

Alvotech is seeking passionate and skilled Combination Product Leads to join our innovative Combination Products and Devices (CPD) team. The CDP team designs and develops drug delivery solutions that are reliable, accessible, and in keeping with patient needs.

The Combination Product Lead is an individual contributor who reports to the Team Lead – Combination Product Leads and works with other Combination Product Leads and Human Factors, Risk, Technical, and program strategy specialists to ensure the successful development, verification and validation of our products and maintenance of our combination drug product files (DHFs and DMRs).

Key Responsibilities:

• Lead the compilation of DHFs for Alvotech’s combination drug product(s) in development, including usability files, design verification testing, and risk assessments.
• Lead the writing of several key deliverables of the design control process.
• Collaborate with specialists to deliver design verification, validation, and risk documentation and design control milestones in alignment with program strategy.
• Coordinate with regulatory bodies to compile technical files for submission, ensuring compliance with MDR 2017/745.
• Maintain technical knowledge in the function, assembly, and testing of injection devices.
• Stay updated on regulations related to combination drug products.
• Author sections of global submission dossiers.
• Contribute to process improvements and SOP drafting.
• Maintain DHF documentation with QA.
• Coordinate document review, updates, and approval for technical projects.
• Responsible for maintenance of DHF and DMR post design transfer and performing design impact assessments for proposed design changes.
• Schedule, manage and present stage reviews.

Qualifications:

• Master’s Degree with a minimum of 5 years of relevant work experience.
• Proven experience in life cycle management of combination products.
• Strong knowledge of design control processes and regulatory requirements (ISO-13485, ISO-14971, MDR, 21 CFR part 4, ISO-11608, IEC-62366, ASTM 1980, ISO 23908 etc.)
• Proficiency in risk management and design verification/validation (ISO-13485, ISO-14971)
• Experience with technical documentation and regulatory submissions.
• Excellent verbal and written English communication skills.
• Ability to work independently and as part of a team.
• Self-motivated, adaptable, and positive attitude.

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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.

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.