Process Development Engineer: Drug Product Tech & Transfer

Crystal Equation Corporation; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Crystal Equation Corporation seeks a candidate with a B.S. or M.S.

in a scientific or engineering discipline to support Process Development and Technology Transfer activities across multiple product lines at aseptic fill-finish facilities in Thousand Oaks, CA. You will plan, execute, and document characterization, process validation, and tech transfer projects, generating technical data packages and communicating findings to cross-functional groups.

Qualifications

• B.S. in a scientific or engineering discipline with 1+ years of experience, or M.S. in a scientific or engineering discipline.
• Familiarity with cGMP and experience in drug product or drug substance manufacturing or process development.
• Knowledge of and hands-on experience with various drug product technologies.
• Demonstrated critical-thinking, problem-solving, and independent research skills.
• Ability to learn new techniques, perform multiple tasks, maintain accurate records, follow instructions, and comply with company policies.
• Excellent project management skills and the ability to elevate relevant issues to the project lead and line management.
• Strong cross-functional teamwork and effective oral and written communication skills.
• Ability to work independently and collaboratively with internal and external partners.
• Strong computer and organizational skills, with close attention to detail.

Responsibilities

• Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials.
• Assist in design and execution of experiments to characterize and enable implementation of new capabilities and process changes, such as filling, lyophilization, and analytical technologies.
• Support technology transfer leads during transfer of drug products to clinical and commercial manufacturing sites, including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments.
• Support the development and maintenance of clinical and commercial technology transfer tools.
• Effectively communicate results of characterization studies, experimental execution, and technology transfer initiatives.
• Author, review, and data-verify technical documents, such as technical protocols, technical assessments, technical reports, draft SOPs, and guidance documents.
• Analyze generated data, including performing statistical analyses using Minitab, JMP, or similar software.
• Develop digital tools and models by leveraging data analytics and programming skills.
• Support at-scale characterization and/or process validation runs as a person in plant.

Skills

Problem solving

Project management

Data analytics

Programming skills

Communication

Independent research

Cross-functional teamwork

Education

B.S. in scientific or engineering

M.S. in scientific or engineering

Tools

SAP

Smartsheet

Minitab

JMP

Job description

Crystal Equation Corporation seeks a candidate with a B.S. or M.S.

in a scientific or engineering discipline to support Process Development and Technology Transfer activities across multiple product lines at aseptic fill-finish facilities in Thousand Oaks, CA. You will plan, execute, and document characterization, process validation, and tech transfer projects, generating technical data packages and communicating findings to cross-functional groups.