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.

• Prior drug product internship or previous drug product work experience
• Experience in large molecule development
• Lab or manufacturing experience

• Support filling operations with operations of manufacturing size fillers
• Performing experiments and data analysis
• Participate in team presentations

• B.S. with 2‒3 years of industry experience, M.S. with 1‒2 years of experience
• 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

• Multiple jobs in short time frame.
• Released from previous EW position due to behavior.
• Pursuing additional education within 1 year.
• Candidate should be enthuastic / highly motivated and willing to learn - this is a very technical and challenging job but is also very awarding.

• 30 min video conf interview with hiring manager (1 staff).

• 1 hr video conf interview with entire team (8 staff).
• Possible 1 hr In-person interview on site in ATO (8 staff).