Process Development Senior Associate (Biotechnology)

Location: Onsite at the corporate headquarters in Thousand Oaks, California, United States

Company

Develops and commercializes innovative biotechnology medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Plan and design formulation and fill/finish process development studies for large-molecule modalities, including monoclonal antibodies, BiTEs, and fusion proteins.
• Execute and accurately document laboratory studies involving ultrafiltration/diafiltration, filtration, freeze-thaw, and stability testing.
• Evaluate product and process performance using analytical techniques such as U/HPLC, particle analysis, and moisture-content testing.
• Build dashboards, data-structuring solutions, automated analyses, and visualizations using tools such as TIBCO Spotfire and MS Smartsheet.
• Analyze data with statistical software and programming tools, and collaborate with engineers and scientists on commercialization and lifecycle management.
• Author and review technical protocols and reports, and present study designs, results, and technical challenges in team meetings.

Requirements

• Master’s degree, or bachelor’s degree plus 2 years of scientific experience, or associate degree plus 4 years of scientific experience, or high school diploma/GED plus 6 years of scientific experience.
• Degree in chemical engineering, biomedical engineering, biochemistry, biotechnology, pharmaceutics, or a related field.
• At least 1 year of pharmaceutical or biotechnology experience involving process characterization, formulation development, equipment design and implementation, or technology transfer.
• Knowledge of drug product unit operations, protein stability, process-related stresses, and relevant analytical techniques.
• Proficiency with at least one statistical software package, such as SAS, JMP, or Minitab, plus experience with programming, databases, or data visualization tools.
• Strong critical thinking, problem-solving, research, organization, communication, and attention-to-detail skills.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans, work-life balance support, and career development opportunities.
• Flexible work models may be available where applicable; sponsorship is not guaranteed.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Reasonable accommodations are available during the application and interview process.