3 дня назад
Associate Scientist (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Scientist (Biotechnology): Developing formulations and processes for large-molecule drug candidates across bispecifics, fusion proteins, monoclonal antibodies, ADCs, and oligonucleotides with an accent on stability characterization, fill/finish development, and protein quality assessment. Focus on designing stability and in-use compatibility studies, applying advanced analytical methods, and preparing technical and regulatory documentation for early-stage therapeutic programs.
Location: Thousand Oaks, California, United States
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
- Develop formulations and processes for large-molecule drug candidates, including bispecific and multispecific proteins, fusion proteins, monoclonal antibodies, ADCs, and oligonucleotides.
- Plan, execute, and document stability studies for liquid and lyophilized formulations and first-in-human development.
- Design in-use compatibility studies that mimic clinical dose preparation and administration.
- Characterize proteins using HPLC/UPLC, 2-D HPLC, subvisible particle analysis, viscosity testing, mass spectrometry, capillary electrophoresis, and biophysical methods.
- Represent drug product process development in cross-functional project teams and support fill/finish process development.
- Prepare protocols, technical transfer documents, reports, product impact assessments, and regulatory sections for IND submissions.
Requirements
- Master's degree, or a bachelor's degree with 2 years of scientific experience, or an associate's degree with 4 years of scientific experience, or a high school diploma/GED with 6 years of scientific experience.
- Knowledge of protein physical and chemical stability and the effects of process-related stress on product quality.
- Experience with antibody characterization, stability studies, and parenteral controlled-release delivery systems.
- Knowledge of ultrafiltration-diafiltration and buffer exchange processes.
- Strong problem-solving, documentation, communication, and cross-functional collaboration skills.
- Sponsorship is not guaranteed.
Nice to have
- Master's degree in pharmaceutics, biotechnology, biochemistry, physical biochemistry, biophysics, or a related field.
- Three or more years of industrial experience in pharmaceutical, biotechnology, or a related field.
- Experience with light scattering, DSF, AUC, FFF, peptide mapping, high-throughput screening, and data analytics.
- Experience with JMP, Tableau, or Spotfire.
Culture & Benefits
- Collaborative, innovative, science-based working environment.
- Health and welfare plans for eligible employees and dependents.
- Financial plans with opportunities to save for retirement and other goals.
- Work-life balance and career development opportunities.
- Inclusive workplace focused on diversity, ethical conduct, and scientific advancement.
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