Top 3 Must Have Skill Sets:
Lab experience, good writing and communication skills, computer skills
Day to Day Responsibilities:
Learn and train staff on analytical equipment and process unit operations. Support multiple product development teams during study execution. Maintain the readiness of the facility for product development (ordering supplies, interface with service and on-site technicians for equipment repairs/PM/Cals), coordinate the facility usage calendar and the facility website.
deal candidate-B.S. with 2-5 years experience, M.S. with 1-3 years experience, with degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or related degree with a biotechnology, pharmaceutical background.
Senior Associate Scientist responsibilities include, but are not limited to, the following:
Independently design and execute studies to characterize Drug Product formulations and processes to deliver robust products.
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.)
Conduct analytical testing of samples, such as measurement of pH, conductivity, osmolality, protein concentration, SEC, CEX, particle concentration, visual appearance.
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
Provide equipment and assay training
Manage interface with project teams for successful execution of studies
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 1-3 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"