Top 3 Must Have Skill Sets:
1. Strong basic Lab experience
2. Process operations (UF/DF, freeze/thaw, filtering, filling)
3. Flexible, motivated individual who has good communication skills
• Independently design and execute studies to characterize Drug Product formulations and processes to deliver robust products.
o Conduct related studies, such as ultrafiltration/diafiltration (UF/DF), filtration, freeze/thaw, filling, and material compatibility, for products in various formulations and formats (liquid, lyophilized, pre-filled syringes, etc.)
o Conduct analytical testing of samples, such as measurement of pH, conductivity, osmolality, protein concentration, SEC, CEX, particle concentration, visual appearance, viscosity, surface tension.
• Independently design and execute experiments in order to characterize and enable implementation of new capabilities that advance state-of-the art automation, high throughput screening, formulation, filling, and analytical technologies
• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
• Serve as single point of contact and subject matter expert (SME) on complex capabilities. Enable walk-up utilization and own business process:
o Write and own SOPs/methods/manuals
o Provide equipment and assay training
o Manage interface with project teams for successful execution of studies
o Maintain equipment procedures, user log books, scheduling, metrics, training, etc.
• 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 Lab Ops, Asset Management, Facilities and vendors to repair
• Author/review technical documents, such as technical protocols, technical assessments, technical reports, regulatory documents
• Assist/coordinate new equipment procurement and installation
• Perform tasks related to safety and compliance initiatives in the lab; inspections and resolution of observations
• Manage inventory levels of commonly used lab supplies and chemicals
• As needed, participate in initiatives, such as integration of Electronic Lab Notebooks (ELN) and lab instruments to streamline and enhance data collection
• Strong scientific skills relevant to Drug Product development
• Display critical thinking, problem solving and independent research skills
• Good computer and organizational skills with strong attention to detail
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Ability to elevate relevant issues to project lead and line-management
• Excellent communication (oral and written)
• Excellent project management skills including the ability to manage project resource requirements (material, manpower, time, etc.)
• Self motivation, adaptability and a positive attitude
• Ability to work independently and as part of a team with internal and external partners
• Ability to participate in cross-functional teams and work effectively in a fast-paced, highly matrixed team environment
• Team leadership and supervision skills
• Experience working with GMP systems
• Experience in process development for Phase I – III biologics
• B.S. with 2-5 years’ experience, M.S. with 0-3 years’ experience, with degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or related degree with a biotechnology, pharmaceutical or vaccine background. Biotech/pharmaceutical industry experience preferred.
"This posting is for Contingent Worker, not an FTE"