BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Chemistry Manufacturing Scientist/Process Engineer to work for a leading San Diego biotechnology company.
Chemistry Manufacturing Scientist/Process Engineer
This position provides direction and support to the manufacturing area utilizing industry standard problem-solving skills and acquired scientific/engineering knowledge to resolve manufacturing issues that impact product quality and delivery. Key activities include, but are not limited to, monitoring of current manufacturing processes, reduction of variation, control/mitigation of process drift, leading / supporting troubleshooting investigations, implementing manufacturing process improvements, assessing feasibility of new manufacturing technology, ensuring manufacturing process robustness, revising/creating new documentation for Manufacturing (manufacturing instructions, routings, bills of material, SOPs, etc), validation of new or improved manufacturing processes and equipment and integrating new products from R&D into manufacturing. Characterize, optimize, validate and ECO manufacturing processes to improve efficiency and robustness of current processes. Leads / supports evaluation of NCMR, CPAR, Failure Investigation and Deviation requests arising from the Chemistry Manufacturing area of problematic manufacturing processes. Leads / supports the audit of manufacturing processes; working with a cross-functional team. Participates in audits, documents results and develops and implements corrective action. Assists Process Engineering group in assigned deliverables from R&D development meetings as it relates to scale up and current production capabilities in Mfg. Executes all tasks in accordance with Quality System and carries out duties in compliance with established business policies.
BA/BS in life sciences or engineering and 5+ years experience within a cGMP manufacturing environment. Good analytical and problem solving skills Good knowledge of process optimization, scale up and standardization. Good organizational skills, and the ability to manage multiple tasks Ability to plan and execute experiments to: -Develop new processes and set specifications - Characterize materials and set specifications - Troubleshoot problems - Write and execute associated validations Ability to work within cross-functional teams. Good communication skills, written and verbal. Knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.). Demonstrates ability to consistently meet proposed objective timelines, applying competent use of project planning and project management skills Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts) Knowledge of related quality system regulations and processes Appropriate computer skills (e-mail, word processing, graphing software) Experience in lateral flow technology preferred.