Scientific Advisor - APL (m/f/d)

Sandoz; Holzkirchen; Hybrid; EUR 1.008.000 - 1.872.000; Vollzeit

Benefits dieser Stelle

Vacation days

Vacation pay

Capital-forming benefits

Company pension

Flex-hybrid work

Learning platforms

Employee share program

Zusammenfassung

Sandoz in Holzkirchen, Germany, is looking for an Analytical Project Lead to oversee all analytical activities in biosimilar development from inception to completion. You will lead the analytical sub-team, ensure quality, and guide registration documents for HA submissions.

The role requires a higher degree in Chemistry/Biochemistry and at least six years of bio/pharma experience, strong leadership, and fluent English.

Qualifikationen

• Higher Degree in Chemistry, Biochemistry, or a related field.
• Minimum of 6 years relevant experience in bio-/pharmaceutical industry.
• Track record and broad knowledge in analytical / technical development of biosimilars.
• Fluent in English (oral and written).

Aufgaben

• Lead, manage and scientifically oversee all analytical tasks in biosimilar projects and coordinate the analytical sub-team.
• Develop analytical project strategies and plans with timelines and milestones.
• Coordinate and compile high quality analytical registration documents for HA submissions and interact with Health Authorities.
• Ensure data integrity and regulatory compliance; interpret results in context.

Kenntnisse

Leadership

Analytical development

Communication skills

Problem solving

Organizational skills

Strategic thinking

Scientific writing

English fluency

Ausbildung

MSc or PhD in Chemistry

Jobbeschreibung

Job Description Summary

Tätigkeitsbeschreibung - Zusammenfassung
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. As Analytical Project Lead you have to ensure that projects are delivered on time, in quality and in budget.

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Lead, manage and scientifically oversee all analytical tasks in biosimilar projects;
  coordinate and lead the analytical sub-team, ensuring alignment with organizational goals and development functions; and further, represent Analytical Development in global, multifunctional CMC project teams.

• Drive and develop analytical project strategies and plans, including timelines, milestones, decision, and ensuring lean development and lean project execution.
  characterization of the API, method-development (fit for purpose and robust), transfer and -validation, specification setting, release and stability testing, know-how transfer, etc.

• Coordinate and compile high quality analytical registration documents for HA submissions and, interact with Health Authorities where appropriate; act as technical expert in audits, inspections.

• Ensure integrity of data and compliance with regulatory guidelines and industry standards and interpret results within relevant context, drawing the right conclusions.

• Provide scientific and technical guidance, actively drive knowledge exchange.

• Develop, mentor and coach principal scientists and other scientific associates.

• Identify, mitigate and manage analytical project risks.

What you’ll bring to the role:

Essential Requirements:

• Higher Degree in Chemistry, Biochemistry, or a related field and minimum of 6 years relevant experience in the bio-/pharmaceutical industry.

• Track record and broad knowledge in analytical / technical development of biosimilars including Health authority interactions, (IND/IMPD/CTA/BLA preparations and submissions)

• Strong communication, interpersonal and problem-solving skills.

• Excellent organizational and leadership skills.

• Good sense for innovation, strategic thinking und open minded personality.

• Proficient scientific/technical writing skills and excellent presentation skills.

• Fluent in English (oral and written)

Compensation Structure & Criteria:

Sandoz compensation is determined by job level, qualifications, niche skills, experience, and location within company salary ranges. Fully proficient and highly effective employees can expect a starting salary around market median, with those new to the level or with less functional depth at the lower end of the range and those with sustained superior or niche skills towards the higher end of the range. Internal equity and external market data inform our range placement. Annual salary reviews consider performance outcomes, market alignment, and business needs.

• Job location: Holzkirchen, Germany

• Starting pay range: EUR 90,300 - 167,700

• Variable compensation: 15% performance-based bonus

• Additional benefits include: 30 vacation days per year (in full time), 1.200€ vacation payment (in full time), €40/month in capital-forming benefits (in full time), company pension, flex-hybrid working 50% per week in the office, access to our learning & development platforms Skillsoft & Learnlight, Access to our employee share program “OurShare”

• Pay frequency: Monthly

• Expected weekly working hours: 40 hours

• Contract type: full time

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

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 only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and 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.

#Sandoz

Skills Desired

Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Project Management