POSITION PURPOSE
The Manager Biosimilars Analytics position is responsible for defining or aligning all relevant activities for biosimilars analytical methods and quality control during development and manufacturing in accordance with latest analytical technologies and regulatory expectations. Provides high-level technical leadership and expertise, coordinating analytical activities of biosimilar programmes to required standards. Acts as technical lead in highly complex projects, drawing upon a broad range of technical know-how to provide carefully thought-through advice and expertise to a range of stakeholders across the organisation. The Manager offers innovative solutions, contributing extensively to development and improvement activities, identifying and addressing future analytical needs of the biosimilar project and alliance teams in order to deliver on Zentiva’s biosimilar strategy.
KEY RESPONSIBILITIES AND ACTIVITIES
- The oversight for development, validation, and execution of physico-chemical, immunochemical, and biological methods for Zentiva’s biosimilars pipeline in close collaboration with internal and external partners.
- Develop and align integrated analytical development, comparability and control strategies and plans that enable efficient cell line/strain development, process development, product characterization,and drug delivery for biosimilar products from project start through regulatory approval, product launch and life-cycle management
- Establish phase-appropriate analytical strategies, including comparability exercises, in partnership with co-development partners and Zentiva’s development functions
- Ensure effective and efficient transfers of methods to internal and external teams as appropriate
- GMP lot release, stability, and in-process testing for all clinical products globally and deviation handling.
- Ensure that all analytical activities comply with regulatory requirements and industry standards
- Stay updated on changes in regulatory policies and guidelines related to all analytical aspects relevant for biosimilars and biologics in general.
QUALIFICATIONS AND EXPERIENCE
- A PhD in analytical sciences
- At least 8 years analytical development work experience within an industrial biotech environment with a proven track record in global Biosimilars development and a strong background in analytical comparability exercises
- Significant theoretical knowledge of and practical experience with the design, verification and utilisation of analytical methods for analysis of therapeutic peptides and proteins, encompassing, quality, functional and stability measures.
- Proven knowledge of FDA, EMA, and ICH guidelines and standards for biopharmaceutical process development and manufacturing and analytical activities involved therein; extensive knowledge of applicable GxP requirements
- Experience in interaction with regulatory agencies of advantage
- Track record in supporting development teams through provision of timely analytical support and advice.
- Experience with the design and delivery of formulation screens to identify optimal excipients for biologic product stability and activity of advantage.
- Experience with working in co-development alliances in an intercultural environment.
- Experience with managing service providers, especially contract development and manufacturing organizations for analytics, drug substance & drug product development, fill & finish and device development.
REQUIRED SKILLS AND COMPETENCIES
- Creative, but science-based thinking in order to identify the best way of demonstrating analytical comparability of a biosimilar with its reference product and consistent quality of that biosimilar during development and production
- Ability to effectively engage with and lead team members in a co-development alliance
- Application of experimental design and statistical concepts to experimental planning of advantage
- Ability to understand complex technical data and communicate them effectively at all levels;
- Demonstrated ability to present complex analytical information to regulatory agencies and other stakeholders
- Familiarity with development, manufacturing and quality assurance processes in biosimilars
- Excellent organizational and planning skills, with demonstrated ability to work effectively in a highly matrixed and cross-functional environment
- High attention to detail, excellent teamwork, communication, networking and interpersonal skills
- Fluent in English (written and spoken)
- Willingness to travel
Top Skills
What We Do
Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.
We are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality and affordable medicines to people who depend on them every day. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated and can be their true selves contributing to the best of their ability.
