Auszug aus der Stellenanzeige von DE71 (FCRS = DE071) HEXAL AG
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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.
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