2 дня назад
Process Development Senior Scientist (Drug Product Technologies)
126 066 - 170 560$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Process Development Senior Scientist (Drug Product Technologies) (Biologics, ADCs, and Oligonucleotides): Developing stable and manufacturable drug products through formulation, process development, analytical characterization, and fill/finish studies with an accent on complex biologic modalities and phase-appropriate development. Focus on integrating formulation, stability, analytical, and process data, investigating modality-specific quality attributes and degradation pathways, and applying AI/ML and automation to accelerate development decisions.
Location: Thousand Oaks, California, United States
Salary: $126,066.05–$170,559.95 annual salary
Company
is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Plan, lead, and execute formulation, stability, process development, and fill/finish studies for early-stage biologic drug product programs.
- Develop and characterize liquid and lyophilized formulations for ADCs, oligonucleotides, monoclonal antibodies, multispecifics, and other complex modalities.
- Integrate formulation, analytical, stability, process, manufacturability, and regulatory data to guide product and development strategies.
- Investigate critical quality attributes, degradation pathways, aggregation, fragmentation, charge and size variants, particles, surface interactions, and modality-specific attributes.
- Apply high-throughput tools, AI/ML, automation, and data science to formulation screening, predictive modeling, workflow acceleration, and decision-making.
- Provide scientific leadership, mentor junior scientists, author technical and regulatory documents, and support technology transfer and manufacturing troubleshooting with internal and external partners.
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.
- PhD in Pharmaceutics, Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with 3+ years of relevant industry experience preferred.
- Experience in biologics drug product formulation, stability assessment, process development, and/or fill/finish operations.
- Knowledge of biologics and complex modality development, including formulation stability, degradation pathways, aggregation, particulates, manufacturability, comparability, and control strategies.
- Experience with analytical and biophysical techniques such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, LC-MS, subvisible particle analysis, viscosity, osmolality, and stability-indicating methods.
- Experience with technical reports, regulatory submissions, clinical-stage development, technology transfer, and risk-based decision-making.
Nice to have
- Direct experience with ADCs, oligonucleotides such as siRNAs, or other complex biologic modalities.
- Experience with linker-payload stability, drug-to-antibody ratio, free payload impurities, ADC quality attributes, and oligonucleotide degradation or formulation stability.
- Experience applying AI/ML, LLMs, in silico tools, automation, or data science to R&D workflows.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus and stock-based long-term incentives.
- Paid time off and career development opportunities.
Hiring process
- Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
- Sponsorship for the role is not guaranteed.
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