Process Development Sr Associate

Role Summary

Process Development Sr Associate based in Thousand Oaks, CA, supporting large molecule drug product formulation and fill/finish process development. Responsible for formulation studies, assessing impact of process stresses on drug product attributes and stability, and defining process parameters for fill/finish operations. Focus on advanced data analytics, visualization tools, and leveraging AI/GenAI to accelerate insights and decision-making.

Responsibilities

• Plan, design, execute, and document studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics (antibodies, BiTEs, proteins, viruses, RNA).
• Perform analytical characterization supporting formulation and stability assessments using chromatography and biophysical tools (SE-HPLC, CE-SDS, DSC, NMR, HIAC).
• Author and review technical protocols, reports, product impact assessments, and regulatory sections for IND and marketing application submissions.
• Apply advanced information systems to improve drug product design by integrating historical data, analyzing large datasets, and performing statistical analysis.
• Create effective data visualizations and use AI/GenAI-driven approaches to generate automated insights, predictive models, and interactive dashboards.
• Explore and evaluate new digital tools to enhance team capabilities in process development and operations.
• Support clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for investigations and changes.
• Contribute to the standardization and optimization of departmental practices by developing and improving guideline documents.
• Deliver progress reports and presentations to ensure management engagement and alignment.

Qualifications

• Basic Qualifications:
  • High school diploma / GED and 6 years of Scientific experience OR
  • Associate‚Äôs degree and 4 years of Scientific experience OR
  • Bachelor‚Äôs degree and 2 years of Scientific experience OR
  • Master‚Äôs degree
• Preferred Qualifications:
  • Master‚Äôs degree in Pharmaceutics, Biotechnology, Engineering, Material Science, or related discipline.
  • 2+ years of experience in pharmaceuticals/biotechnology, including new product development, process characterization, formulation, technology transfer, and statistical analysis of experiments.
  • Experience with drug product formulation and fill/finish unit operations (freeze/thaw, formulation, mixing, filtration, filling, inspection).
  • Strong understanding of protein stability and the impact of process stresses on product quality; experience with RNA or virus modalities is a plus.
  • Proficiency in statistical software (e.g., SIMCA, JMP).
  • Expertise in data visualization tools (e.g., Tableau, Spotfire) and coding/scripting for automated data analysis and modeling.
  • Aseptic processing experience and familiarity with cGMPs.
  • Experience with regulatory filings and compliance for sterile injectable products.
  • Strong problem-solving, cross-functional communication skills, and ability to act on dynamic information at a rapid pace.

Skills

• Data analytics and visualization
• AI/GenAI-driven insights
• Formulation and fill/finish process understanding
• Statistical analysis
• Regulatory compliance knowledge for sterile products
• Problem-solving and cross-functional collaboration

Education

• Master‚Äôs degree preferred; other degrees considered with appropriate scientific experience as listed above.

Additional Requirements

• Able to travel as needed for role requirements (not explicitly stated in source).