Process Development Engineer - Technical Transfer Leader

ACL Digital; Thousand Oaks (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

ACL Digital is seeking a CW Associate Scientist in Thousand Oaks, CA to support technical transfer and lifecycle-management activities for commercial drug product fill-finish processes.

The role involves transfers between development and manufacturing sites, collaboration with Process Development, Manufacturing, Quality, Regulatory, and Analytical Sciences, and developing scientifically rigorous documentation.

Qualifications

• 3+ years of drug product process development, manufacturing support, or technical transfer experience.
• Hands-on laboratory and drug product process experience to understand underlying science and document technical results.
• Experience in IV bag preparation, compatibility, or administration-system studies is a plus.

Responsibilities

• Author, verify, and review technical transfer documents, study protocols, and regulatory-support docs.
• Compile and interpret development and manufacturing data to support transfer, validation, and filings.
• Perform laboratory analytical testing (viscosity, protein concentration, pH, osmolality, etc.).
• Perform lab experiments including pipetting, formulation, mixing, filtration, sampling, and product-contact evaluations.
• Provide technical support for drug product fill-finish processes (formulation, mixing, filtration, filling of vials, syringes, devices).
• Assist with development/characterization of drug product processes and tech transfer between development and commercial sterile sites.

Skills

Technical transfer

Drug product manufacturing

Lab experimentation

Cross-functional collaboration

Data analysis

Job description

ACL Digital is seeking a CW Associate Scientist in Thousand Oaks, CA to support technical transfer and lifecycle-management activities for commercial drug product fill-finish processes.

The role involves transfers between development and manufacturing sites, collaboration with Process Development, Manufacturing, Quality, Regulatory, and Analytical Sciences, and developing scientifically rigorous documentation.