Director Analytical Characterization (m/f/d)

DE71 (FCRS = DE071) HEXAL AG; Holzkirchen; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

30 days of annual leave

Holiday allowance

Company pension scheme

Access to learning platforms

Job summary

DE71 (FCRS = DE071) HEXAL AG is seeking a leader for the Analytical Characterization department in Holzkirchen, Germany. This role requires extensive experience in the technical/analytical development of Biosimilars and a Ph.D. in a relevant discipline.

The successful candidate will oversee the workflow, ensuring compliance, resource optimization, and strategic planning. The position offers a dynamic work environment with 30 days of annual leave and various employee benefits.

Qualifications

• Extensive industry experience in the technical/analytical development of Biosimilars.
• 10+ years of experience in leading large teams in Analytical Development or adjacent R&D teams.
• Fluency in English, spoken and written.

Responsibilities

• Lead and manage the Analytical Characterization department within Biosimilar technical development.
• Drive the evolution of the team and improve current processes.
• Provide scientific and managerial leadership for analytical characterization.

Skills

Budget Management

Coaching Skills

Data Science

Experiment Design

Laboratory

NPI (New Product Introduction)

People Management

Problem Solving Skills

Process Simulation

R&D

Waterfall Project Management

Education

Ph.D. in a relevant technical discipline

Job description

Job Description Summary

The analytical characterization team located in Holzkirchen near Munich focuses on characterizing target molecules and driving analytical similarity assessments. The team is part of Sandoz's global Biosimilar Technical Development organization, currently sized over 50 associates, and may further grow in relation to portfolio demand.

Your Key Responsibilities

• Lead and actively manage the Analytical Characterization department within Biosimilar technical development, driving a culture of exceptional performance and continuous improvement, enabling innovative, competitive, compliant, and consistent delivery on objectives of teams, projects, networks, and/or platforms.
• Drive the evolution of the team and improve current processes to match the evolving landscape and requirements while actively leading that change.
• Provide scientific and managerial leadership to efficiently perform the analytical characterization of Biosimilar candidates.
• Create and implement reliable yet cost-efficient methods, processes, and procedures - ensuring staying within budget and optimizing resource utilization.
• Ensure adherence to current regulations and data integrity in development.
• Address complex R&D issues and collaborate across technical development line functions.
• Evaluate and implement new related scientific technologies.
• Build and maintain a highly agile and efficient organization that can flexibly react to changing priorities.
• Understand and meet individual program and customer needs and ensure team activities are aligned with overall biosimilar development processes.
• Drive the Analytical Characterization strategic plan and its implementation.
• Ensure current and future needs are fully met, adequately resourced, delivered on time and in full compliance.

What You’ll Bring to the Role

• Extensive industry experience in the technical/analytical development of Biosimilars.
• Ph.D. in a relevant technical discipline with 10+ years of experience.
• Experience leading large teams in Analytical Development or adjacent R&D teams in global technical development organizations.
• Track record in leading change and process improvement initiatives.
• Proven servant-leadership skills leading teams through ambiguous times.
• Distinguished R&D leadership with exceptionally broad and in-depth knowledge in Analytical Development/Characterization and adjacent disciplines.
• Thorough knowledge of relevant regulations and regulatory guidelines and a proven successful track record of BLA submission and regulatory health authority interactions.
• Excellent communication and presentation skills.
• Advanced coaching and mentoring skills.
• Strategic thinking and ability to lead in a matrix organization.
• Fluency in English, spoken and written.
• Lean Six Sigma certification is a plus.

Required Skills

• Budget Management
• Coaching Skills
• Data Science
• Experiment Design
• Laboratory
• NPI (New Product Introduction)
• People Management
• Problem Solving Skills
• Process Simulation
• R&D
• Waterfall Project Management

Benefits

• 30 days of annual leave.
• Holiday allowance.
• Additional rewards for special occasions (e.g., service length awards, marriage celebration).
• Company pension scheme and capital formation benefits.
• Parental leave.
• Bike leasing.
• Access to Coursera and other learning platforms with more than 200,000 learning videos and 5,000+ courses.

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.