8 дней назад
Process Development Senior Principal Scientist (ADC Biologics)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Process Development Senior Principal Scientist (ADC Biologics): Developing and commercializing biologic drug product formulations and fill/finish processes with an accent on ADC formulation, linker-payload stability, analytical characterization, and technology transfer. Focus on applying AI/ML and data science, leading matrixed drug product teams, and solving formulation, manufacturing, and regulatory challenges for late-stage biologics.
Location: Thousand Oaks, California, United States; onsite role with up to 10% domestic and international travel.
Company
is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Lead laboratory studies for drug product design, formulation, process development, documentation, and technology transfer.
- Develop and characterize liquid and lyophilized biologic formulations, with emphasis on ADC drug products and lab-scale sterile filling.
- Integrate formulation, analytical, stability, and process data to guide product design and commercialization.
- Lead internal and external technology transfers, process-fit assessments, CMO/CDMO collaboration, and manufacturing troubleshooting.
- Apply AI, machine learning, and data science to predictive modeling, workflow acceleration, and decision-making.
- Lead matrixed drug product teams and manage engineers and scientists supporting commercialization and lifecycle management.
Requirements
- PhD, PharmD, or MD plus 2 years of scientific experience; or a master’s degree plus 5 years; or a bachelor’s degree plus 7 years.
- Experience in pharmaceutical or biotechnology development, including formulation, fill/finish process development, process characterization, technology transfer, and design of experiments.
- Direct ADC drug product formulation experience is strongly preferred, including linker-payload stability, drug-to-antibody ratio, degradation pathways, quality attributes, and comparability.
- Strong knowledge of biologic formulation, stability testing, aseptic processing, manufacturing, analytical and biophysical techniques, and regulatory authoring.
- Experience with programming and data tools such as Python, R, MATLAB, SQL, Tableau, Spotfire, or D3, plus statistical software such as SAS, JMP, or Minitab.
- Ability to lead global multifunctional teams, solve complex problems, influence stakeholders, and learn new technologies rapidly.
Culture & Benefits
- Collaborative, innovative, science-based environment focused on serving patients.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions and stock-based long-term incentives.
- Discretionary annual bonus program and award-winning time-off plans.
- Career development opportunities and flexible work models where applicable.
- Visa sponsorship is not guaranteed.
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