Hi there, I'm Siddhi, Talent Expert with Collabera LLC. Hope this message finds you well! We're actively hiring for top performers, and I think you could be a great fit. Why apply now? Positions are filling fast, and we're hiring immediately. If this resonates with you, I'd love to chat about how your background aligns with this opportunity. Let's explore if it's the right next move for you. Ready to connect?

Email:

siddhi.kadakia@collabera.com or

Phone:

(847

• 440-1112

Position Details:

Client Industry:

Pharmaceutical/Medical Device/Biotechnology Title:

Scientist I

•

Fill/Finish & Drug Product Process Development Location:

Irvine, California, 92612

Duration:

3 months ++ possibility of extension based on performance and business needs

Shift:

USA Standard Business Hours Shift Pay Rate:

$37.00

• $42.

00 per hour

Job Details:

Looking for entry-level scientific contractors, with 4-year scientific degrees What are the top 3-5 skills, experience or education required for this position: Ability to understand, set up, and operate moderately complex automated fill/finish equipment for production of prefilled syringes. With minimal supervision, familiarity with setting up and performing laboratory processes. Use of equipment including mixing vessels, filters, tanks, and associated utilities and connections. Ability to document information, e.g., from syringe measurements, using good laboratory/manufacturing processes (GLP/GMP) in electronic systems, with excellent writing proficiency. Excellent communication skills, ability to work within a team setting, and follow strict adherence to quality requirements. Basic understanding of MS office tools, and ability to independently draft technical documents. 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.

Basic Qualifications:

• Bachelor's Degree in engineering, pharmaceutical sciences, chemistry, pharmaceutics, or related disciplines.
• Laboratory skills and experience with automated equipment.
• Scientific problem solving, experimental design, and trouble shooting skills.

Preferred Qualifications:

• Experience in a regulated manufacturing or laboratory environment.
• Familiarity with sterile processing or fill/finish operations.

Additional Important Role Notes:

The position is primarily onsite, hands-on laboratory and fill-finish activities. The Scientist will support drug product fill-finish operations in Irvine, California, with a focus on prefilled syringe processing and inspection.

The role will primarily involve:

Manual visual inspection of prefilled syringes. Defect checking and product quality assessments. Plunger depth measurement. Loading syringes into packaging configurations. Supporting fill-finish activities and related operations. Maintaining accurate documentation, data, and reports in accordance with Good Documentation Practices (GDP). Following Standard Operating Procedures (SOPs) and working under the guidance of experienced team members.

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. Direct syringe fill experience is not mandatory. Candidates with aseptic technique or related experience can be trained.

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 , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually

• These all are subject to applicable eligibility).