biotechnologypharmaceuticalsIrvine, CA
Scientist Fill - Finish Drug Product Process Devel
Scientist Fill - Finish Drug Product Process Devel
Scientist Fill - Finish Drug Product Process Devel
biotechnologypharmaceuticalsIrvine, CA
6 days ago
Pharmaceutical Preparation ManufacturingResearch and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)Biological Product (except Diagnostic) Manufacturing
Apply for this role →Scientist I - Fill/Finish & Drug Product Process Development The U.S. Parenterals and Drug Product Team within Process Development, Science, and Technology (PDS&T) is a global organization that supports drug product process development, commercial site scale up, and tech transfer. The candidate will support manufacturing and laboratory operations in a regulated environment. This role is responsible for assisting with the setup, operation, and documentation of moderately complex automated fill/finish equipment used in the production of prefilled syringes, as well as performing routine laboratory and manufacturing processes under minimal supervision. The ideal candidate will demonstrate strong attention to detail, clear communication skills, and a commitment to quality, compliance, and teamwork.
Responsibilities:
- Understand, set up, and operate moderately complex automated fill/finish equipment for prefilled syringe production.
- Set up and perform routine laboratory and manufacturing processes with minimal supervision.
- Work with equipment and systems including mixing vessels, filters, tanks, and associated utilities and connections.
- Accurately document activities and results in electronic systems in accordance with GLP/GMP requirements.
- Independently draft clear and accurate technical documents as needed.
- Excellent communication skills, ability to work within a team setting, and follow strict adherence to quality requirements.
- Use MS Office tools to support documentation and reporting tasks.
- Top Non-Negotiable Requirements:
- Drug product experience: Familiarity with drug product operations, particularly fill-finish activities.
- GMP/GDP knowledge: Understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).Teamwork: Ability to collaborate effectively with team members across upstream and downstream operations.
Preferred Technical Skills:
- Fill-finish operations.
- Aseptic processing and cleanroom experience.
- Manual visual inspection and defect identification.
- Prefilled syringe handling.
- Plunger depth measurement.
- SOP compliance and documentation.
- Laboratory equipment operation.
- Preferred Educational Backgrounds:
- Chemical Engineering
- Mechanical Engineering
- Biomedical Engineering
- Pharmaceutical Sciences
- Candidates with degrees in Chemistry, Biology, or Biochemistry may also be considered. Education Flexibility:
- Bachelor's and master's degree holders are welcome.
- Fresh graduates can be considered.
- Candidates without a bachelor's degree may be considered if they have relevant fill-finish experience.
Experience Level:
No strict minimum or maximum years of experience. The hiring manager is open to candidates across experience levels, provided their skills align with the role and they are interested in the hands-on responsibilities.
Relevant Experience:
- Drug product fill-finish – Highly relevant
- Cleanroom work – Highly relevant
- Aseptic technique – Relevant; training possible
- Pharmaceutical internships – Relevant
- Co-op experience – Relevant
- University laboratory experience – Considered
- Candidates must be comfortable with:
- Hands-on laboratory work.
- Operating equipment.
- Handling and moving materials.
- Performing repetitive inspection and defect-checking tasks.
- Following SOPs and working under supervision.
- Supporting operational activities rather than focusing exclusively on research or formulation development.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually.
Also on the board Same function, level within a rung
Level
Junior
Location
Irvine, CA
Occupation
Chemical Technicians
Industry
Pharmaceutical Preparation Manufacturing
Posted
6 days ago