To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $40 to $45 an hour (Negotiable base on the experience)

Client Industry: Pharmaceutical

Job Mode: Onsite

Contract Duration: 12 Months (++possibilities of Extension)

Description:

This role supports the development and manufacturing of biologic products by performing cGMP-compliant, cell-based laboratory assays. The position is responsible for generating high-quality analytical data, maintaining laboratory compliance, and supporting regulated manufacturing and quality systems. The role plays a critical part in ensuring data integrity, regulatory readiness, and the reliability of laboratory operations. The individual will work closely with quality, manufacturing, and technical teams to support clinical and commercial supply needs.

Must Haves:

• Experience working in a GMP-regulated laboratory environment
• Hands-on experience with cell-based bioassays
• Proficiency in quality systems including laboratory investigations, change controls, and non-conformances
• Experience with aseptic cell culture techniques
• Strong understanding of laboratory data integrity and documentation requirements
• MS in Chemistry, Biochemistry, Cell Biology, or related field with 3+ years industry experience
  OR BS in Chemistry, Biochemistry, Cell Biology, or related field with 5+ years industry experience

Day to Day:

• Perform cGMP-compliant cell-based potency assays to support biologics manufacturing
• Complete assigned laboratory testing accurately and within required timelines
• Generate, compile, analyze, and evaluate assay data for technical reports
• Review and approve raw data, laboratory notebooks, and worksheets
• Perform routine aseptic cell culture and cell banking activities
• Manage critical laboratory reagents, materials, and supplies
• Author and support quality system records including deviations, investigations, and change controls
• Support internal and external regulatory inspections as required
• Ensure laboratory equipment is properly used, maintained, and documented
• Support equipment qualification, validation, and preventive maintenance activities
• Create, revise, and maintain standard operating procedures (SOPs)
• Follow all environmental, health, and safety procedures and policies
• Maintain compliance with laboratory documentation and computerized system data integrity requirements

Plusses:

• Experience with Chemi-ECL ELISA
• Experience with PCR methodologies
• Exposure to automated assay platforms
• Experience with cell banking programs
• Proficiency with Excel and project tracking tools
• Experience supporting regulatory inspections (FDA, EMA, ISO)

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 - AS Applicable)