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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Manufacturing Science & Technology Specialist II/Senior Specialist - **Company:** United Therapeutics - **Location:** Silver Spring, MD, United States - **Experience:** Expert - **Salary:** $77,000.0 - $102,000.0 - **Contract:** Permanent contract - **Skills:** Data Analysis, Microsoft Office, Software Tools, GXP - **Published:** August 15, 2026 - **Apply:** https://www.techcareers.com/job.asp?id=3354584796&tx=JT989TYI&pt=1&aff=0B19D771-A501-4A5E-8338-2A822B784D54&utm_source=Job%20Feed&utm_medium=textkernel&utm_campaign=DE&utm_term=0B19D771-A501-4A5E-8338-2A822B784D54 ## About the Role 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, 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 ## Description 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 ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [ Secure Code Superstars: Empowering Developers and Surpassing Security Challenges Together](https://www.wearedevelopers.com/videos/422-secure-code-superstars-empowering-developers-and-surpassing-security-challenges-together) - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Designing How Work Feels: The Science Behind Sanofi’s Workplace Experience](https://www.wearedevelopers.com/videos/1848-designing-how-work-feels-the-science-behind-sanofi-s-workplace-experience) - [Old tools, new tricks](https://www.wearedevelopers.com/videos/1916-old-tools-new-tricks) - [Geometric deep learning for drug discovery](https://www.wearedevelopers.com/videos/264-geometric-deep-learning-for-drug-discovery) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer) - [A Guide to Green Tech and Green IT Careers](https://www.wearedevelopers.com/magazine/374-a-guide-to-green-tech-and-green-it-careers) - [How to Write a CV and Interview if You Don't Fully Qualify For The Job](https://www.wearedevelopers.com/magazine/183-how-to-write-a-cv-and-interview-if-you-don-t-fully-qualify-for-the-job) - [Best Companies to Work For in Germany: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/33-best-companies-to-work-for-in-germany-top-25-companies-in-2023)