Biosample Operations Lead (all genders)

Biopharma Careers; Warszawa; On-site; PLN 260,000 - 420,000; Full time

Benefits offered by this job

Private medical care

Life insurance

Sports card

Prepaid lunch card

Flexible working hours

Language courses subsidy

Training and certifications

Employee assistance program

Job summary

Biopharma Careers is seeking a Biosamples Operations Lead to own end-to-end biosamples work across global Phase I-III studies. You will translate clinical biosamples requirements into actionable operations, coordinating across laboratories and vendors to safeguard sample quality and study delivery.

The role requires a PhD or MSc in Life Sciences, 6+ years in clinical development, and fluency in English. You will work with global teams, influence stakeholders, and drive timely decisions in a

Qualifications

• Master’s degree or higher in Biology, Biomedical Science, Biotechnology, Pharmacy, Medicine or Life Science disciplines.
• Minimum 6 years of clinical development experience with biosamples operations.
• Strong scientific and clinical laboratory understanding of biosamples and handling.

Responsibilities

• End-to-end ownership of biosamples operations across global Phase I-III studies.
• Lead complex operational discussions with cross-functional teams and labs.
• Identify gaps and risks; translate requirements into executable solutions to protect sample quality and data integrity.
• Manage relationships with laboratory vendors and support timely decision making.

Skills

Biosamples operations

ICH-GCP knowledge

Cross-functional leadership

Vendor management

Risk assessment

Autonomy under pressure

English fluency

Education

Master’s degree or higher in Biology/Life Sciences

Job description

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Clinical biosamples are where science meets clinical operations – where even routine operational decisions can determine the quality and reliability of the data the resulting data.

Delivering results in biosamples operations combines scientific understanding with the operational judgement to translate complex requirements into effective solutions.

Your Role:

As Biosamples Operations Lead, you will take end-to-end ownership of biosamples operations across global Phase I-III clinical studies, acting as custodian of clinical biosamples throughout their lifecycle. Bringing your scientific and clinical laboratory understanding into practice, you will critically assess biosamples requirements, anticipate their operational implications and translate them into executable solutions. You will anticipate gaps, dependencies and risks, critically evaluate information and use your experience and judgement to drive pragmatic solutions that protect sample quality data integrity and study delivery. Across global cross-functional study teams and laboratory partners, your role is to lead complex operational discussions, challenge assumptions when needed, negotiate effective solutions and drive timely decisions across competing priorities. This level of ownership brings both the autonomy to make informed, timely decisions and responsibility for their outcomes.

Who you are:

• Master’s degree or higher in Biology, Biomedical Science, Biotechnology, Pharmacy, Medicine or relevant Life Science disciplines
• Minimum 6 years of relevant experience in clinical development with a demonstrated track record of direct responsibility for clinical biosamples operations, including substantial interaction with clinical laboratories and/or biomarker operation within a pharmaceutical company, biotechnology company, CRO or clinical laboratory environment
• Strong scientific and clinical laboratory understanding including biosamples types, pre-analytical variables, samples processing, stability, storage and analytical requirements relevant to clinical studies
• Demonstrated experience managing end-to-end operational lifecycle of clinical biosamples across global clinical studies, including Phase I-III development, central and/or specialty laboratory operations and complex biosample logistics
• Strong working knowledge of ICH-GCP principles and their application where relevant
• Proven ability to identify and assess operational risks, critically evaluate information and translate complex biosamples requirements into practical and executable solutions
• Demonstrated experience working with global cross-functional teams and laboratory vendors, including influencing stakeholders, challenging assumptions, negotiating solutions and driving decisions in complex or time-sensitive situations
• Experience with central laboratory budget planning, forecasting and vendor performance management
• Demonstrated ability to operate autonomously, apply sound of judgement under pressure and take responsibility for decisions and their outcomes
• Professional fluency in written and spoken English

Desired Experience and Capabilities:

• Phd in Biology, Biomedical Science, Biotechnology, Pharmacy, Medicine or relevant Life Science disciplines
• Experience supporting complex biomarker, PK/PD, immunogenicity, and/or molecular testing requirements in clinical development
• Experience with companion diagnostics (CDx) and/or compels specialty laboratory testing
• Strong understanding of biobanking, ICF, sample retention and secondary-use considerations in clinical development

YOUR MAIN BENEFITS:

• Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card
• Work-Life balance: Enjoy additional paid days off, flexible working hours.
• Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities
• Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection.

Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!