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The job details are as follows:

The MS&T Specialist II/Sr. Specialist is responsible for supporting manufacturing in a commercial operations environment. This position is responsible for assisting in the investigation and resolution of manufacturing deviations, non-conformances, and out-of-specification results, supporting the execution of manufacturing change controls, assisting in process development and optimization studies, troubleshooting manufacturing issues, and ensuring the smooth transfer of new products and processes into commercial production. The Specialist II/Sr. Specialist will work closely with manufacturing, quality, engineering, regulatory, and validation teams to ensure robust, efficient, and compliant pharmaceutical operations.

• Assist in the investigation and resolution of manufacturing deviations, non-conformances, and out-of-specification results
• Support root cause analysis efforts for process-related issues, providing data and technical insights
• Support in the execution of manufacturing change controls
• Perform process monitoring & data analysis to monitor process performance, identify trends, and support continued process verification
• Participate in process improvement initiatives to enhance yield and efficiency
• Partner cross-functionally with Engineering, Manufacturing, Quality, Automation, Validation, and Regulatory teams on manufacturing process and equipment projects
• Aid in the technology transfer of new pharmaceutical processes/products to manufacturing
• Contribute to the preparation of process documentation, including batch records, SOPs, and technical reports
• Contribute technical expertise for regulatory filings and assist during internal and external audits

Minimum Requirements

Manufacturing Science & Technology Specialist II

• Bachelor's Degree in biology, chemistry, biochemistry, or closely related field
• 2+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations
• Familiarity with investigational tools such as Fishbone diagrams, 5 Why's, and Failure Mode and Effects Analysis to solve manufacturing deviations
• Ability in experiment planning, design, execution, optimization, data analysis, interpretation, and communication
• Basic knowledge of GXP guidelines for the biotech industry
• Proficient technical writing skills for preparation of summary reports
• Good organizational skills
• Ability to interpret data critically
• Familiar with Microsoft Office and other common software tools

Preferred Qualifications

• Master's Degree in biology, chemistry, biochemistry, or closely related field
• 5+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations
• Experience with design of experiment studies and software for process optimization
• Familiarity with Fill Finish processes
• Familiarity with Cell Culture and Purification processes
• Ability to perform statistical evaluation of data
• Hands-on experience with specific equipment categories such as bioreactors, purification skids, and fill-finish lines
• Ability to perform basic maintenance of equipment
• Experience with scale-up small scale cell culture and transfer to a cGMP facility for full scale manufacturing
• Understanding of validation lifecycle principles and regulatory guidance
• Familiarity with Benchling or other electronic laboratory notebook software

Minimum Requirements

Sr. Manufacturing Science & Technology Specialist

• Bachelor's Degree in biology, chemistry, biochemistry, or closely related field
• 5+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations
• Mastery of investigational tools such as Fishbone diagrams, 5 Why's, and Failure Mode and Effects Analysis to solve manufacturing deviations.
• Ability to work independently in experiment planning, design, execution, optimization, data analysis, interpretation, and communication
• Knowledge of GXP guidelines for the biotech industry
• Proficient technical writing skills for preparation of summary reports
• Good organizational skills
• Ability to interpret data critically
• Familiar with Microsoft Office and other common software tools
• Ability to perform basic maintenance of equipment

Preferred Qualifications

• Master's Degree in biology, chemistry, biochemistry, or closely related field
• Experience with design of experiment studies and software for process optimization
• Practical skills in reading process/equipment P&IDs (Piping and Instrumentation Diagrams) and working with manufacturing automation systems
• Familiarity with Fill Finish processes
• Familiarity with Cell Culture and Purification processes
• Ability to perform statistical evaluation of data
• Hands-on experience with specific equipment categories such as bioreactors, purification skids, and fill-finish lines
• Experience with scale-up small scale cell culture and transfer to a cGMP facility for full scale manufacturing
• Understanding of validation lifecycle principles and regulatory guidance
• Familiarity with Benchling or other electronic laboratory notebook software

Job Location

This role is based 100% onsite at our Silver Spring, MD location.

The salary range for the Manufacturing Science & Technology Specialist II position is $77,000 - $102,000 per year, and the salary range for the Senior Manufacturing Science & Technology Specialist position is $92,500 - $125,000.

These ranges reflect our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities