8 дней назад
Process Development Senior Scientist (ADC Biologics)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Process Development Senior Scientist (ADC Biologics): Developing commercial formulations and fill/finish processes for late-stage biologics, with an accent on ADC formulation, stability, analytical characterization, and manufacturability. Focus on integrating formulation and process data, applying AI/ML for predictive modeling, and solving technical challenges across scale-up, technology transfer, and manufacturing campaigns.
Location: Thousand Oaks, California, United States; onsite work supporting laboratory formulation, sterile filling, and manufacturing activities.
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
- Participate in drug product commercialization teams for pipeline development and lifecycle management of commercial products.
- Design, execute, and document formulation and process development studies for liquid and lyophilized biologics.
- Develop ADC drug product formulations, handling procedures, and lab-scale sterile filling processes.
- Build process understanding across unit operations, evaluate stability and in-use compatibility, and support scalable manufacturing.
- Apply statistical analytics, AI, machine learning, and data science to predictive modeling and technical decision-making.
- Prepare technical, regulatory, risk assessment, control-strategy, and technology-transfer documentation; support CMO/CDMO transfers and manufacturing troubleshooting.
Requirements
- Doctorate degree, or a master’s degree with 2 years of scientific experience, or a bachelor’s degree with 4 years of scientific experience.
- Experience in biologics formulation development, stability testing, and fill/finish operations; direct ADC drug product formulation experience is strongly preferred.
- Understanding of ADC development, including linker-payload stability, drug-to-antibody ratio, degradation pathways, quality attributes, and comparability.
- Experience with analytical and biophysical techniques such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
- Ability to integrate formulation, stability, and analytical data and contribute to regulatory submissions such as CTAs and BLAs.
- Strong scientific communication and cross-functional collaboration skills.
Nice to have
- PhD in Pharmaceutics, Biotechnology, Biochemistry, or a related field.
- 2–4 years of postdoctoral or industry experience.
Culture & Benefits
- Collaborative, innovative, science-based working environment.
- Health, 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 and career development opportunities.
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