Process Development Associate

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This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$25.00/hr - $27.00/hr

Supplement additional workload on team

• Lab
  
  Experience:
  
  Hands‑on experience in a laboratory setting is crucial. This includes familiarity with lab equipment, techniques, and safety protocols.
• Work in a Team:
  The ability to collaborate and work well within a team is essential. This involves effective communication, cooperation, and the ability to contribute to group projects.
• Communication:
  This includes drafting technical reports, presenting study objectives and results, and facilitating discussions.

The staff should be onsite. Tasks will include participating in various trainings to stay updated with the latest techniques and protocols. Prepping the workstations will be necessary to ensure that all equipment and materials are ready for use. Executing the study will involve conducting experiments and gathering data.

Recording data in real‑time in an electronic notebook is crucial for maintaining accurate and up‑to‑date records. Data analysis and writing reports will be required to summarize findings. Data verification of various documents will be another important task to ensure the integrity and accuracy of the information.

Additionally, maintaining certain lab equipment will be essential to ensure everything is functioning properly and safely. This comprehensive set of responsibilities will help ensure the smooth operation of the lab and the success of projects.

Yes

• Inability to Work in a Team
• Lack of Lab Experience
• Inconsistent Data Recording and Analysis
• Neglecting Equipment Maintenance

An initial phone interview with the hiring manager and then a panel of interview. The interview will be through Web Ex or Teams.

Let’s do this. Let’s change the world. In this vital role you will work in our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). Additionally, the position works on ways to improve how data is analyzed and the use of statistical models to inform decisions throughout drug product development.

The Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.

• Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management.
• Work independently, taking ownership of projects and self‑managing work packages with appropriate communication and partner concern.
• Apply basic science/engineering skills and first principle modeling to solve technical problems.
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non‑conformance investigations and process changes/improvements.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs.
• Ability to travel domestically and internationally up to 10% of the time.

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