Job Description

• Independently design and execute experiments in order to characterize and enable implementation of new capabilities such as filling, lyophilization and analytical technologies
• Serve as single point of contact and subject matter expert (SME) on complex capabilities.
• Own business process and responsible for maintaining line time request forms and metrics
• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
• Conduct analysis of data generated from any of the above listed activities, including statistical analysis using SAS, JMP etc., and effectively communicate results
• Troubleshoot malfunctioning equipment, work with system owners, Asset Management, Facilities and vendors to repair
• Author/review technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures
• Perform tasks related to safety and compliance initiatives in the lab.
• Manage procurement and inventory levels of commonly used lab supplies and chemicals
• Manage dynamic project schedules and timelines

• B.S. with 2 years of industry experience, M.S. with 1 years’ experience, with degree in Engineering
• Previous experience in drug product/ drug substance manufacturing or process development labs
• Knowledge of and hands-on experience with various drug product technologies, particularly filling technology
• Displayed critical thinking, problem solving and independent research skills
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Good computer and organizational skills with strong attention to detail

• Excellent communication (oral and written)
• Excellent project management skills including the ability to manage project resource requirements material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management
• Self-motivation, adaptability and a positive attitude
• Ability to work independently and as part of a team with internal and external partners
• Experience working in GMP environments or process development
• Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses

• Self-motivated
• Familiarity with large molecule processing operations / biotechnology production
• Technically capable and willing to learn - familiarity with Teams/ Sharepoint administration is a big plus.

• Support operation of commercial grade fillers
• Scheduling, data analysis, coordination of operating activities
• Writing, reviewing, and developing procedures and SOPs for routine operation

• Excessive short-term positions in multiple companies in a short time window
• Candidate searching to apply for higher education in the next 1-2 years
• Candidate should have consistent industry experience (preferred)