Scientific Advisor - APL (m/f/d)

Job Description Summary

As Analytical Project Lead you will oversee and drive all analytical aspects in biosimilar development projects from inception to completion.

This role requires a strong background in biosimilar development, analytical methodologies, technical development and team leadership.

You must ensure that projects are delivered on time, in quality and in budget.

Key Responsibilities

• Lead, manage and scientifically oversee all analytical tasks in biosimilar projects.
• Coordinate and lead the analytical sub‑team, ensuring alignment with organisational goals and development functions.
• Represent Analytical Development in global, multifunctional CMC project teams.
• Drive and develop analytical project strategies and plans, including timelines, milestones and decisions, ensuring lean development and execution.
• Characterise the API, develop methods (fit for purpose and robust), transfer and validate, set specifications, perform release and stability testing and transfer know‑how.
• Coordinate and compile high‑quality analytical registration documents for Health Authority submissions and interact with Health Authorities when appropriate; act as technical expert in audits and inspections.
• Ensure data integrity and compliance with regulatory guidelines and industry standards, interpret results within the relevant context, drawing the right conclusions.
• Provide scientific and technical guidance and actively drive knowledge exchange.
• Develop, mentor and coach principal scientists and other scientific associates.
• Identify, mitigate and manage analytical project risks.

Essential Requirements

• Higher degree in Chemistry, Biochemistry, or a related field and a minimum of 6years relevant experience in the biopharmaceutical industry.
• Track record and broad knowledge in analytical and technical development of biosimilars, including Health Authority interactions (IND/IMPD/CTA/BLA preparations and submissions).
• Strong communication, interpersonal and problem‑solving skills.
• Excellent organisational and leadership skills.
• Good sense for innovation, strategic thinking and an open‑minded personality.
• Proficient scientific and technical writing skills and excellent presentation skills.
• Fluency in English (oral and written).

Compensation and Benefits

• Salary range: €90,300 – €167,700 per year, plus a 15% performance‑based bonus.
• Variable compensation and a range of benefits including: 30 vacation days, €1,200 vacation payment, €40 per month capital‑forming benefits, company pension, flexible hybrid working (50% office attendance) and access to learning and development platforms.
• Job Location
• Holzkirchen, Germany (full‑time)
• Employment Details

Contract type: full time; Expected weekly working hours: 40 hours; Pay frequency: monthly.

Commitment to Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Hiring decisions are based only on the qualifications for the position, regardless of gender, ethnicity, religion, sexual orientation, age or disability.

The law provides for severely disabled/equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process.

If you would like to request this, please let us know in advance as a note on your CV.

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