22 часа назад
Process Development Senior Principal Scientist (ADC)
157 737 - 213 409$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Process Development Senior Principal Scientist (ADC drug product development): Leading formulation, fill/finish, process development, and technology transfer for late-stage biologics with an accent on ADC stability, linker-payload attributes, analytical characterization, and manufacturability. Focus on applying AI/ML and data science to predictive modeling, leading matrixed drug product teams, and resolving technical challenges during commercialization and manufacturing campaigns.
Location: Thousand Oaks, California, United States; travel domestically and internationally up to 10% of the time.
Annual salary: USD 157,737.05–213,408.95.
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, handling, and sterile filling.
- Integrate formulation, analytical, stability, and process data to guide product design and commercialization.
- Lead technology transfers with internal teams and CMOs/CDMOs, including process-fit assessments 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 with 2 years of scientific experience; or a master’s degree with 5 years; or a bachelor’s degree with 7 years.
- Advanced degree in engineering, pharmaceutics, biotechnology, material science, or a related field.
- At least 8 years of experience in pharmaceuticals or biotechnology, including formulation, fill/finish process development, process characterization, technology transfer, and design of experiments.
- Experience with biologic formulation development, stability testing, aseptic processing, manufacturing, regulatory authoring, and agency engagement; direct ADC formulation experience is strongly preferred.
- Knowledge of ADC development, including linker-payload stability, drug-to-antibody ratio, degradation pathways, quality attributes, comparability, and analytical techniques such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, and CE-SDS.
- Programming and data skills in Python, R, or MATLAB; SQL; data visualization tools; and statistical software such as SAS, JMP, or Minitab.
Culture & Benefits
- Collaborative, innovative, science-based work environment.
- Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
- Flexible work models where applicable to the posted work location.
Hiring process
- Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
- Sponsorship for the role is not guaranteed.
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