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Manager Biosimilars Analytics

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As the Manager Biosimilars Analytics you will be responsible for defining and aligning all activities related to analytical methods and quality control for biosimilars during development and manufacturing, in line with the latest technologies and regulatory expectations. You will provide high-level technical leadership and coordinate analytical activities across biosimilar programs to ensure compliance with required standards. Acting as technical lead for complex projects, you will offer expert guidance across the organization. You will contribute to innovation and continuous improvement, identifying and addressing future analytical needs to support the success of Zentiva’s biosimilar strategy and alliance collaborations.

In this role you will:

Provide 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.
Oversee GMP lot release, stability, and in-process testing for all clinical products globally and manage 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

To be successful in this role you will need:

PhD in analytical sciences and at least 8 years of analytical development experience in an industrial biotech setting, with a strong track record in global biosimilars development and analytical comparability.
Deep theoretical and hands-on experience with analytical method design, verification, and application for therapeutic peptides and proteins, including quality, functional, and stability assessments.
Proven knowledge of FDA, EMA, and ICH guidelines, GxP requirements, and biopharmaceutical process development standards relevant to analytical activities.
Demonstrated ability to support development teams with timely analytical expertise and to present complex data effectively to regulatory agencies and other stakeholders.
Experience working within co-development alliances and managing service providers (CDMOs, CROs) across analytics, drug substance/product development, and device development.
Strong leadership, organizational, and communication skills, with the ability to work effectively in cross-functional, intercultural, and matrixed environments.
Fluent in English and willing to travel as required.

Our Recruitment Process:

To be considered for this role, please apply in our Applicant tracking system and refrain from sending your CV via email. Upon the completion of sourcing (CV collection) period, all received application will be reviewed by our Recruitment experts and evaluated against the needs of the open role. Successful candidates will be contacted by our Recruiting experts for an initial screening interview during which further details about the selection process will be shared. Successful candidates will progress to interviews with line managers, while not selected candidates will be informed in a written form as soon as possible.

Diversity is a fact. Inclusion is an act @Zentiva

At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.

Join our winning team! Be a part of our winning culture! Be Zentiva!

Average salary estimate

$135000 / YEARLY (est.)

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$120000K

$150000K

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What You Should Know About Manager Biosimilars Analytics, Zentiva

As the Manager Biosimilars Analytics at Zentiva, you'll step into an exciting role where you will lead all analytical methods and quality control activities related to biosimilars throughout their development and manufacturing process. With cutting-edge technology and dynamic regulatory expectations at your fingertips, you will provide crucial technical leadership, coordinating analytical activities across various biosimilar programs to ensure they meet the highest standards. Your expert guidance will be essential as you navigate complex projects and foster innovation and continuous improvement strategies. You will oversee the development and execution of physico-chemical, immunochemical, and biological methods, working alongside internal and external partners to support the biosimilar pipeline. You will also establish analytical strategies, ensuring that all methodologies remain compliant with regulations while effectively transferring methods to teams as needed. By staying ahead of changes in regulatory policies, you will ensure Zentiva's biosimilars remain at the forefront of the industry. To thrive in this role, a PhD in analytical sciences coupled with significant industry experience in biosimilars development is essential, along with strong leadership and organizational abilities. If you're passionate about making a difference in healthcare and want to collaborate with a diverse and talented team, we invite you to join Zentiva's efforts in enhancing health and well-being for all generations.

Frequently Asked Questions (FAQs) for Manager Biosimilars Analytics Role at Zentiva

What are the primary responsibilities of the Manager Biosimilars Analytics at Zentiva?

The Manager Biosimilars Analytics at Zentiva is responsible for defining and aligning all analytical activities for biosimilars during development and manufacturing. This includes providing high-level technical leadership, coordinating analytical activities across various biosimilar programs, inventing strategies for analytical development, and ensuring compliance with regulatory requirements. The role requires oversight of method validation and execution and managing GMP lot releases.