Process Development Engineer

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

The ideal candidate will have at least 3 years of drug product process development, manufacturing support, or technical transfer experience in the pharmaceutical or biotechnology industry. Candidates may come from a scientific or engineering background and may have held previous titles such as Associate Scientist, Scientist, or Engineer.

This role will have a strong focus on technical transfer documentation, data evaluation, and cross-functional project support. The candidate must also have sufficient hands‑on laboratory and drug product process experience to understand the underlying science, critically evaluate study results, and develop technically sound documentation.

Previous Client or broader pharmaceutical industry experience is preferred. Experience supporting intravenous bag preparation, compatibility, or administration‑system studies is a plus.

Job Description

We are seeking a CW Associate Scientist to support technical transfer and lifecycle‑management activities for commercial drug product fill‑finish processes. The individual will support transfers between development and manufacturing sites and will work closely with Process Development, Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering, and other cross‑functional partners.

The role will emphasize preparation and review of technical transfer documentation, study protocols, reports, process assessments, product impact assessments, and regulatory‑support documents. The candidate will also support process characterization and laboratory‑based activities as needed.

The successful candidate will have a strong understanding of end‑to‑end drug product manufacturing, including formulation, mixing, hold operations, sterile filtration, filling, lyophilization, and product‑contact systems. Time will be divided between supporting laboratory and process‑development activities and developing clear, scientifically rigorous technical documentation.

Key Responsibilities

• Author, data‑verify, and review technical transfer documents, study protocols, technical reports, product impact assessments, data summaries, and regulatory‑support documentation.
• Compile, analyze, and interpret development and manufacturing data to support technical transfer, process characterization, validation, and regulatory filings.
• Execute laboratory analytical testing, including viscosity, protein concentration, pH, osmolality, and other relevant product‑quality measurements.
• Execute laboratory experiments involving pipetting, formulation, mixing, filtration, sampling, and product‑contact evaluations.
• Provide technical support for drug product fill‑finish processes, including formulation, mixing, filtration, and filling of vials, syringes, devices, and other parenteral presentations.
• Assist with the development and characterization of drug product processes and transfer of technologies between development and commercial sterile fill‑finish sites.
• Support commercial drug product activities involving sterile processing, process characterization, technical transfer, validation, and lifecycle management.
• Evaluate site‑to‑site differences in equipment, materials, scale, process parameters, and manufacturing procedures.
• Collaborate with Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering, and other support functions to advance technical transfer and commercial manufacturing activities.
• Participate in global cross‑functional teams and work effectively within a highly matrixed environment.
• Troubleshoot drug product processing technologies and equipment using data‑driven analyses and visualizations to identify root causes and recommend solutions.
• Support product‑contact, IV bag, compatibility, or administration‑system studies, as needed.