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Manufacturing Staff Scientist (Analytical Biochemistry)

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Manufacturing Staff Scientist (Analytical Biochemistry)

  • 2020-13003
  • Hercules, California, United States

Bio-Rad is looking for a Staff Scientist with extensive experience in analytical biochemistry development and troubleshooting for the Reagents Manufacturing Process Development team.  The individual will execute cross-functional projects related to development and continuous improvement for our product lines with a focus on Protein Chemistry and Molecular Biology Reagents, digital PCR reagents and the Bio-Plex suspension array system. 

 

The successful candidate will utilize his/her expertise in analytical biochemistry to support new products for transfer into manufacturing, to identify root cause to materials and to introduce improvements in material sourcing and manufacturing processes. 

Responsibilities

  • Development, optimization and validation of analytical methods to support NPIs (New Product Introductions) and existing processes.
  • Analytical characterization and root cause troubleshooting of new and existing materials.
  • Scale up, optimization and validation existing manufacturing biochemical processes and supportive analytical QC methods.
  • Develop methods to characterize and monitor in process protein purification.
  • Contribute studies and/or activities necessary for process optimization and continuous improvement to assure robust and cost-effective manufacturing processes.
  • Collaborate with R&D and operations functions to ensure on-time, robust, and cost-effective transfer of new products/QC methods into manufacturing.
  • Work with external suppliers to resolve raw material quality issues.
  • Author, update or review validation test plans & data summary, production documents. Setup change control/infrastructure.  Train manufacturing personnel.
  • Requires strong problem solving skills, technical proficiency, collaboration with key stake holders and ability to work independently.
  • Lead & establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Action Plan, Risk Analysis, etc.)
  • Lead and/or manage projects that comprise team members from cross functional areas
  • Design experiments to meet requirements, support manufacturing and transfer both internal and external processes.
  • Drive development & execution of complex experiments & tests (including writing & executing protocols) to qualify & validate manufacturing processes; analyze results, make recommendations, & develop reports
  • Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians & provide feedback & coordinate engineer/ technician work.
  • Advise, review experimental design, protocol, and reports of fellow scientists
  • Mentor technical personnel in process capability, developing training & technical documentation for production to enable the seamless project & process knowledge transfer.
  • Lead efforts to identify & ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., Six Sigma & LEAN methods) employing technical design skills ensure equipment, tools, fixtures, processes are characterized and lean.
  • Lead efforts to drive operational excellence, leveraging data to identify improvement opportunities and ensuring implementation of well-engineered solutions
  • May serve as an Independent Reviewer for design review or lead automation, and leading edge process improvement, and/or provide process strategic guidance to the management team.
  • Lead team to resolve complex CAPA, analyze & resolve complex Manufacturing & compliance issues (e.g., CAPA, non-conformances, audit observations)
  • Works in a team environment, including frequent inter-organizational & outside customer contacts
  • 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.
  • Represents manufacturing in key quality management system such as Design Review Board, Change Control Board, Validation Review Board, etc

Qualifications

  • Master/Doctorate Degree in Analytical Chemistry, Biochemistry, Chemistry or related discipline.
  • Minimum of 6+ years industry experience in analytical developments highly desirable for this position.
  • Proven track record in protein, bioconjugation or macromolecular characterization
  • Experience in protein biochemistry, biophysical, analytical characterization methods, and protein modification using chemical methods.
  • Must have in-depth knowledge and hands-on experience in analytical method development (not limited to HPLC, CE, LC-MS, UV, FLD, BioAnalyzer, etc) and characterization for biologics.
  • Strong analytical and troubleshooting skills; must deliver results in a timely way.
  • Proven expertise in usage of MS Office Suite; DOE methods preferred.
  • Excellent documentation, communication skills, & interpersonal relationship skills including negotiating & relationship management skills.
  • Ability to translate technical information to all organization levels.
  • Extensive knowledge of engineering and scientific principles, theories, & concepts.s
  • Advanced problem solving in organizational, analytical, & critical thinking skills.
  • Extensive to expert level understanding of processes, equipment, and methods in 2-3 technical areas
  • Strong leadership skills in a technical area to influence process improvement & change.
  • Able to apply scientific training to solve manufacturing and operational issues.
  • Ability to build relationships through inter-organization collaboration
  • Experience with ERP system – SAP preferred

 

About Bio-Rad:

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.

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Agency Non-Solicitation: 

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.

 

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