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Process Development Mgr I

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Process Development Mgr I

  • 2020-14228
  • Woodinville, WA, United States

The Process Development Manager provides expertise, vision, and leadership for the transfer and manufacturing support for our consumables and diagnostic tests that align with our immunodiagnostics and infectious diseases business objectives.  Provides technical oversite to the manufacturing organization in all activities that impact quality, manufacturability and/or efficiency.  Fosters a culture of innovation, ownership and individual development within the Process Development team through effective mentoring and lead-by-example principles.  Develops and validates production processes and documentation in accordance to GMP/FDA/GMED bodies in order to insure regulatory compliance.

Responsibilities

  • Assists new product development teams, transfers of new products, processes, equipment, tools, and fixtures to full scale manufacturing, and ensures the integration of qualification/validation activities into the process by initiating, directing, and developing strategies.
  • Leads efforts to develop new and improve existing analytical methods.
  • Writes/reviews development reports and test methodologies.
  • Presents individual project progress/issues.
  • Prepares and/or reviews experimental or study protocols.
  • Collaborates with Marketing, Manufacturing, and R&D teams to determine product definition and specifications.
  • Collaborates with Marketing, R&D, and Sales to resolve customer complaints.
  • Establishes Standard Cost (including the routing and BOM information in SAP for new products) in collaboration with Production and Finance.
  • Represents Manufacturing on various divisional cross-function boards and teams.
  • Facilitates information flow between team members, management, and other departments.
  • Assigns tasks to project staff.
  • Reviews project team technical work product.
  • Prepares and reviews staff schedules.
  • Executes other projects as assigned.

Qualifications

Education:  Master's/PhD or equivalent in Chemistry, BioChemistry, Immunology or related field.

 

Experience:  6+ years experience leading project teams in a manufacturing or R&D environment at a comparable level, or equivalent combination of education and experience.  2+ years of managerial experience.

 

Skills:

  • Proven experience developing and implementing complex manufacturing solutions.
  • Scientific knowledge associated with bio-conjugation and in particular particle coupling and antibody conjugation.
  • Experience in process scale-up. (bench-scale to production)
  • Knowledge in fundamental protein purification techniques, such as IEX, reverse phase, HIC, and SEC.
  • Knowledge of GMP/ISO Manufacturing and QC systems.
  • Experience evaluating new techniques and procedures for product development and optimization.
  • Advanced project management, communication (verbal and written), planning, critical thinking, tact, and budgeting skills required.
  • Ability to influence decisions by presenting clear and compelling ideas and approaches.
  • Proven ability to use statistical methods for troubleshooting and process qualification, particularly Statistical Design of Experiments, Control Chart analysis, and Measurement Systems analysis.
  • Strong problem solving skills including root cause analysis.
  • Experience with instrumentation and control systems, lean manufacturing, six sigma, process failure modes and effects analysis, equipment qualification, and automated system validation (including software validation) preferred.
  • Experience with SAP preferred.
  • Experience developing subordinates and building high performance teams across multi-departmental organizations

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.

 

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing 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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