Senior Process Development Scientist Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: Technical Product Development
Quidel has an opportunity in a new department that is supporting the transfer of innovative products from R&D to the manufacturing environment. Responsibilities of the Senior Process Development Scientist include
providing direction, oversight and analysis to new product development activities through manufacturing process development and mapping of critical processes and materials. The Senior Scientist will:
Ensuring manufacturing process robustness for new and existing lateral flow assays through designing, planning, hands on testing and results analysis.
Assessing feasibility of new manufacturing processes and technologies for transfer to Quidel.
Validation of new or improved manufacturing processes and equipment and integrating new products from R&D into manufacturing.
Revising/creating new documentation for Manufacturing (manufacturing instructions, routings, bills of material, SOPs, etc.).
Technical support to Process Engineering in addressing issues that may or can cause product supply interruptions.
Develop scientific plans and approaches, plan and manage projects.
Identify and resolve assay process performance issues as required.
Collaborate with internal and external resources.
Summarize experimental data and draw conclusions independently.
Provides technical direction and mentoring to lower level employees.
Maintain project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process
Maintain a safe working environment
Education and Experience:
BA/BS in life sciences and/or skills usually associated with 15+ years of relevant industrial experience with demonstrated progressively increasing responsibility or PhD in life sciences plus at least 8 years relevant experience.
Strong analytical and problem solving skills
Strong knowledge of process optimization, scale up and standardization.
Strong 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
- Work on the bench and analyze product performance based on visual characteristics
Ability to work within cross-functional teams.
Strong communication skills, written and verbal.
Strong 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.
Quidel is proud to be an Equal Opportunity/Affirmative Action Employer (M/F/D/V).
||Athens, OH 00000 |
THIS JOB HAS EXPIRED