Manufacturing Science & Technology Specialist II/Senior Specialist

United Therapeutics•Silver Spring, MD

10d•Onsite

About The Position

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.

Requirements

Bachelor’s Degree in biology, chemistry, biochemistry, or closely related field
2+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations (for Specialist II)
5+ years of experience in biopharmaceutical industry, with a knowledge of cGMP regulations (for Sr. Specialist)
Familiarity with investigational tools such as Fishbone diagrams, 5 Why’s, and Failure Mode and Effects Analysis to solve manufacturing deviations (for Specialist II)
Mastery of investigational tools such as Fishbone diagrams, 5 Why’s, and Failure Mode and Effects Analysis to solve manufacturing deviations (for Sr. Specialist)
Ability in experiment planning, design, execution, optimization, data analysis, interpretation, and communication (for Specialist II)
Ability to work independently in experiment planning, design, execution, optimization, data analysis, interpretation, and communication (for Sr. Specialist)
Basic knowledge of GXP guidelines for the biotech industry (for Specialist II)
Knowledge of GXP guidelines for the biotech industry (for Sr. Specialist)
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 (for Sr. Specialist)

Nice To Haves

Master’s Degree in biology, chemistry, biochemistry, or closely related field
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
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
Practical skills in reading process/equipment P&IDs (Piping and Instrumentation Diagrams) and working with manufacturing automation systems (for Sr. Specialist)

Responsibilities

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