Description:
KEY RESPONSIBILITIES
The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group. This group supports commercial operations across a diverse network of manufacturing facilities and external partners.
Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
• Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
• Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.
• Reviews manufacturing processes, deviations, and/or development and production data.
• Reviews manufacturing batch records, protocols, and control strategies.
• Provide technical support and data analysis for investigations and deviation resolution.
• Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
• Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments.
• Oversees and reports on overall manufacturing progress.
BASIC QUALIFICATIONS
• Bachelor’s degree in engineering or science with 5 years of experience
OR
• Master’s degree in engineering or science with 3 years of experience
• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations
PREFERRED QUALIFICATIONS
• Experience with Good Manufacturing Practices and supporting a commercial facility
• Experience in cell culture and/or downstream purification (direct lab experience a plus)
• Experience with equipment qualification and process validation
• Familiarity with formal root cause analysis and/or risk assessment
• Experience working with statistical analysis software and investigative data analysis
• Experience with project leadership
• Experience communicating with cross functional teams
• Strong technical writing and communication skills
• Proficient in Microsoft Word, Excel, and PowerPoint
SPECIAL WORKING CONDITIONS
• Ability to gown and gain entry to manufacturing areas
• Ability to travel (up to 20% of time)
...customers and their people can thrive. Job Description We have a fantastic opportunity within Unit4 for a New Business Senior Sales Representative to join our successful sales team. In this senior role, you will be directly responsible for selling Unit 4's...
...Time Off ~ Hilton Travel Benefits JOB SUMMARY : Responsible for the overall success of the hotel, meeting or exceeding planned objectives given by General Manager, and ensuring guest satisfaction and product quality standards are met with little to no oversight...
...composition, surface temperature, non-destructive inspection of components, etc. The core business of MetroLaser is in the defense sector, NASA and DOE and as a commercial provider of flow and combustion diagnostics. We have an exciting opening for a Holography...
...Comprehensive Community Hospital is looking to hire a Hematologist Oncologist to work in North Central MT! Join a collaborative and diplomatic team that provides expert care in a nurturing environment! Hematologist Oncologist Benefits and Features : ~$650,0...
...Position: Sales Consultant Employment Type: Full-Time/ Part-Time Company Overview: Shes Happy Hair is a leading provider of premium quality hair extensions, dedicated to empowering individuals through beauty and confidence. With retail stores across the United...