Manufacturing Engineer Manager II ( Process Development and Transfer Manager )

11 - 15 years experience  • 

Salary depends on experience
Posted on 03/27/18
11 - 15 years experience
Salary depends on experience
Posted on 03/27/18

Overview

Bio-Rad Laboratories is a leading manufacturer of life science and diagnostic products that service a diverse range of customers within the Academic, Healthcare, Biotechnology/Basic Research and Pharmaceutical sectors.

These products are used to advance basic research, healthcare treatments, therapeutic discoveries and purification of biological materials at laboratory and process scales. We have an opportunity for a senior Process Development and New Technology Transfer Manager at our Hercules facility with a focus in Molecular Biology and specifically PCR product lines.

Responsibilities

  • Strong organizational, leadership and communication skills.
  • Able to communicate to senior executives in Management, Marketing and R&D on a regular basis details for financial and project updates.
  • Able to develop action plans for high level project requests from the business leaders.
  • Extensive hands-on experience in Biochemical Manufacturing environments, with an emphasis on the manufacturing of Molecular Biology products. Knowledge of droplet digital PCR technology would be a distinct advantage.
  • Oversee a team of scientists for technical transfer of new products into the manufacturing environment, continuous improvement projects for current products, and/or troubleshooting of current products.
  • Lead efforts to develop new assays and improve existing analytical methods.
  • Ownership of the writing of development reports and test methods.
  • Provide technical guidance into content of validation and qualification plans.
  • Able to use statistical methods for troubleshooting and process qualification, particularly Statistical Design of Experiments, Control Chart analysis, and Measurement Systems analysis.
  • Be a resource to manufacturing personnel on the application of statistics to manufacturing issues.

Qualifications

  • Bachelor's Degree in Chemistry, Biochemistry, Molecular Biology or related discipline with at least 10 years of industry experience.
  • Previous cGMP experience would be a distinct advantage.
  • Proficient in the development and optimization of assays, as well as method qualification, method transfer to QC and troubleshooting.
  • Knowledge of statistical approaches to trend manufacturing and QC data and define specifications based on process capability.
  • Knowledge of MiniTab would be an advantage.
  • Proficient in the use of SAP for creating and managing Materials and Process information.
  • Excellent interpersonal and communication skills.
  • Works well in a cross functional team environment, both independently as well as be willing to help others.
  • Ability to handle multiple projects, demonstrate initiative and accountability, and strong attention to detail.

Requisition ID 2018-6111

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