Bio-Rad is seeking a Manufacturing Staff Scientist with Leadership skills. The successful candidate will provide product and process support for manufacturing in polymer chemistry, supply chain and quality control department.
- Become a leader/mentor in managing scientist level project assignments and managing work flows, reports, validations, etc.
- Lead and/or manage projects that comprise of team members from cross functional areas
- Identifying root causes of product failures and determining batch specific rework if necessary, revise Material Specs, Production and Quality Control Procedures as indicated by investigations. Provides originality and creativity to problem solving
- Solutions have impact on short and long term department performances
- Manage costs and develop budgets
- Exercises independent judgment in developing methods, validation techniques, and evaluation criteria
- Represents organization in providing solutions to difficult technical issues associated with specific projects and contracts
- Interacts with senior external representatives on significant technical matters often requiring coordination between organizations/divisions
- Represents manufacturing in key quality management roles such as the Design Review Board, Change Control Board, Validation Review Board, etc.
- Assumes an advisory role, reviewing experimental design, and protocols
- Leads efforts to drive operational excellence, leveraging data to identify improvement opportunities and ensuring implementation of well-engineered solutions
- Drives the development and execution of complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
- Lead team to resolve complex CAPA, analyze and resolve complex Manufacturing and compliance issues (e.g., non-conformances and audit observations)
- Mentors technical personnel in process capability, developing training and technical documentation for production to enable the seamless project and process knowledge transfer
- Leads and establish complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Action Plan, Risk Analysis, etc.)
- Provide instruction to engineers/ technicians on conducting tests; train engineers/production team and provide feedback
- As needed coordinates engineer/ production team assignments/work.
- May be selected as an Independent Reviewer for design review or lead automation, and leading edge process improvement, and/or provide process strategic guidance to management team.
- Create new materials in SAP. Complete and initiate Deviation and Non-conformance (QN) Reports.
- Perform instrument validation and maintenance as needed. Participate in the new product introduction and Scale up.
- Implement Management of Change work process to review and control changes required to drive improvement.
- PhD in Chemistry, Chemical Engineering or related disciplines in chemical processing field with emphasis on polymer chemistry.
- 10 to 15 years of industry experience.
- Proven expertise in usage of MS Office Suite.
- Design of experiments (DoE) methods preferred.
- Excellent documentation, communication skills, and interpersonal skills including negotiating and relationship management skills.
- Ability to translate and articulate technical information to all organization levels.
- Extensive knowledge of scientific principles, statistical techniques, theories, and concepts.
- Advanced problem solving in organizational, analytical, and critical thinking skills.
- Strong leadership skills in a technical area to influence process improvement and change.
- The ideal candidate will be able to write clear comprehensive reports and communicate effectively in a cross-functional team.
- Familiarity with various analytical instruments and techniques i.e. HPLC, FPLC, IR. FTIR & GC are preferred.
- Familiarity with Lean Six Sigma, validation requirements and GMP principles is desired.
- SAP experience preferred.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.