Sr Associate Scientist ( Drug Product)
- El Camino Real, Thousand Oaks, CA, USA
Ideal 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.
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.
• 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 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.
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.