11 дней назад
Process Development Associate - Microbiology (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Process Development Associate - Microbiology (Biotech): Executing laboratory studies for microbiological method development, optimization, troubleshooting, and validation with an accent on endotoxin, microbial challenge, bacterial retention, sterile filtration, and rapid microbiology methods. Focus on analyzing experimental data, preparing technical documentation, applying compendial and regulatory requirements, and collaborating with QC, manufacturing, quality, and process development teams.
Location: US - California - Thousand Oaks
Company
is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Execute laboratory studies supporting microbiological method development, optimization, troubleshooting, and validation.
- Conduct endotoxin, low endotoxin recovery, microbial challenge, hold time, bacterial retention, and sterile filtration studies.
- Evaluate alternative technologies, recombinant reagents, Monocyte Activation Tests, and rapid microbiology methods.
- Analyze experimental data and prepare protocols, technical assessments, study summaries, and reports.
- Collaborate with QC Microbiology, Process Development, Manufacturing, Quality, and other cross-functional partners.
- Support laboratory operations, inventory management, materials ordering, and scientific and technical meetings.
Requirements
- Bachelor’s degree, or an associate’s degree with 4 years of microbiology or related biological science experience, or a high school diploma/GED with 6 years of relevant experience.
- Hands-on microbiology and aseptic technique experience.
- Experience in a microbiological quality laboratory or similar environment.
- Knowledge of compendial microbiological methods, including bioburden, bacterial endotoxins, and sterility testing.
- Ability to independently organize and execute laboratory studies, manage priorities, analyze data, and prepare technical documentation.
- Proficiency with project and data management tools such as SharePoint and Smartsheet.
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.
- Annual bonus program 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.
- Reasonable accommodations are available for the application and interview process.
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