1 час назад
Process Development Principal Scientist (Biotech)
141 837 - 191 897$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Process Development Principal Scientist (Biotech): Leading analytical development and manufacturing process research for protein-based biotherapeutics with an accent on protein characterization, stability-indicating assays, and product quality attributes. Focus on designing experiments, interpreting complex analytical data, developing and troubleshooting methods, and preparing regulatory documentation for drug substance and drug product development.
Location: Thousand Oaks, California, United States
Salary: $141,836.95–$191,897.05 annually
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 research and development efforts for manufacturing processes and analytical assessment of pre-pivotal biotherapeutic candidates.
- Represent Attribute Sciences on cross-functional project teams and collaborate across multidisciplinary groups.
- Design and interpret experiments to understand therapeutic protein attributes and stability characteristics.
- Develop, qualify, troubleshoot, and evaluate analytical methods using CE, SEC, IEX, RP, HILIC, HPLC/UPLC, and mass spectrometry.
- Support drug substance and drug product process development, analytical data generation, comparability, and technology transfer.
- Author regulatory documents and evaluate emerging analytical technologies.
Requirements
- PhD, PharmD, or MD with 2 years of scientific experience; or a master's degree with 5 years of scientific experience; or a bachelor's degree with 7 years of scientific experience.
- Strong knowledge of protein biochemistry and protein-based biotherapeutics.
- Expertise in analytical method development, qualification, troubleshooting, experimental design, and complex data interpretation.
- Understanding of critical quality attributes including aggregation, fragmentation, deamidation, oxidation, and partial reduction.
- Ability to work independently, meet timelines, and communicate scientific results effectively in a multidisciplinary environment.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
- Retirement and savings plans with company contributions.
- Annual bonus program, stock-based long-term incentives, time-off plans, and career development opportunities.
- Flexible work models may be available where applicable; sponsorship is not guaranteed.
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