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 per hour

Industry: Medical Device

Work Type: Onsite

Contract Duration: 06 Months Contract Possible Extension

Job Summary:

We are seeking a highly skilled Senior Scientist to support reagent manufacturing and process development within a regulated environment. This role involves leading validation activities, designing experiments, and driving process improvements. The ideal candidate will bring strong expertise in statistical analysis, quality systems, and scientific problem solving. This position requires cross functional collaboration to ensure high quality and efficient manufacturing processes. The role plays a critical part in ensuring compliance and advancing process reliability.

Key Responsibilities:

• Draft and execute validation protocols including operational qualification performance qualification process validation and test method validation
• Design and conduct experiments to evaluate reagent combinations concentrations and operating conditions
• Analyze experimental data and present findings to support decision making and process improvements
• Develop and maintain data tracking tools for process parameters and quality attributes
• Create and revise standard operating procedures manufacturing documents and technical specifications
• Collaborate with research and development and quality teams to improve product and process performance
• Ensure compliance with quality management systems and validation procedures

Required Qualifications:

• Bachelor degree in Biology Chemistry Engineering or related scientific discipline
• Minimum 6 years of experience in scientific technical role within operations manufacturing or research
• Hands on experience with process validation including OQ PQ PV and test method validation
• Experience with design of experiments and statistical analysis
• Proficiency in Minitab or JMP
• Experience working within quality management system.
• Strong documentation and technical writing skills

Preferred Qualifications:

• Master degree in Biology Chemistry Engineering or related field
• Experience in diagnostics or immunoassay technologies
• Exposure to reagent manufacturing processes
• Experience with data visualization tools
• Familiarity with project management tools

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)