Process Development Associate

ACL Digital; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

ACL Digital is seeking a candidate for a Process Development and Project Management role focused on drug product technologies and manufacturing capabilities. The position will support senior staff in planning, executing, and documenting characterization, process validation, and technology transfer activities across multiple products.

The role emphasizes strong documentation, group coordination, and on-the-job development of technical expertise within aseptic fill-finish environments.

Qualifications

• Bachelor's degree in a scientific or engineering discipline is required or preferred.
• Master's degree may be suitable if strong interpersonal and communication skills are demonstrated.
• Experience with software tools beyond Microsoft Office, such as SAP or Smartsheet, is desirable but can be learned on the job.

Responsibilities

• Support senior staff in developing and characterizing drug product technologies and manufacturing capabilities.
• Assist with process validation and technology transfer activities for multiple products across production lines at aseptic fill-finish facilities.
• Execute characterization studies and other experiments at lab and production scales to generate technical data packages and organize/analyze data under supervision.
• Interface with cross-functional drug product teams to support technology transfer and document findings.

Skills

Interpersonal communication

Documentation

Project coordination

Process development mindset

Education

Bachelor's degree in science or engineering

Master's degree beneficial

Tools

SAP

Smartsheet

Job description

The ideal candidate for this role should have a bachelor’s degree in a scientific or engineering discipline. Candidates with a recent master’s degree may also be suitable if they demonstrate strong interpersonal and communication skills. The candidate should have experience with software tools beyond Microsoft Office, such as SAP or Smartsheet, although these tools can be learned on the job. Prior drug product knowledge is not required; however, the candidate should excel in group coordination, meeting deadlines, and maintaining meticulous documentation.

This position emphasizes process development (PD) and project management (PM) skills, with technical expertise expected to develop over time.

As a member of the Process Development team, the candidate will support senior staff in developing and characterizing drug product technologies and manufacturing capabilities. The candidate will also assist with process validation and technology transfer activities for multiple products across various production lines at the aseptic fill-finish manufacturing facilities

The candidate will support senior staff in planning, executing, and documenting characterization, process validation, and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at laboratory and production scales to generate technical data packages using complex technologies, while organizing data and analyzing results under the supervision of senior staff.

The candidate will interface with various drug product teams to support the successful technology transfer of products and the associated documentation. The candidate will assist in establishing experimental designs, developing and executing protocols, obtaining reproducible and reliable results, analyzing and documenting experimental results, and communicating findings to cross-functional groups