Technology Transfer Lead (Pharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Technology Transfer Lead (Pharma): Leading sterile GMP drug product technology transfers from clinical development through first commercial launch with an accent on process setup, scale-up, documentation, and regulatory compliance. Focus on implementing aseptic manufacturing processes, managing cross-functional risks and changes, and resolving deviations and CAPAs across GMP manufacturing sites.
Location: Onsite in Stein, Switzerland, supporting the Drug Product branch in Basel and Stein.
Company
is a global life sciences manufacturing company with more than 30 sites across five continents, helping customers develop and manufacture medicines.
What you will do
- Lead technical transfer activities for sterile GMP drug product manufacturing projects.
- Manage drug product transfers from clinical development through the first commercial launch.
- Define project scope, timelines, risks, and milestones, and track progress.
- Lead process setup, scale-up, and implementation at GMP manufacturing sites.
- Prepare technical transfer and process implementation documentation, and support regulatory submissions, inspections, audits, and customer interactions.
- Drive GMP change management and manage deviations and CAPAs when required.
Requirements
- Master’s degree or Ph.D. in pharmaceutical sciences, pharmaceutical engineering, chemistry, biochemistry, or a related field, or an equivalent qualification.
- Significant experience in the biotech or pharmaceutical industry.
- Knowledge of technical requirements and challenges related to drug product technology transfers.
- Knowledge of aseptic manufacturing for protein drug products; experience with lyophilization and highly potent drug products or ADCs is desirable.
- Strong leadership, interpersonal, planning, organizing, project management, and risk management skills, including experience managing cross-functional teams.
- Excellent written and spoken English is required.
Nice to have
- Experience with lyophilization processes.
- Knowledge of ADC or highly potent drug product manufacturing.
Culture & Benefits
- Agile career opportunities and a dynamic work culture.
- Inclusive and ethical workplace.
- Performance-based compensation programs.
- Collaborative environment focused on innovation and improving patient treatment.
- Commitment to diversity and inclusion.
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