Specialist Product Failure Analysis Lab
Location:
Berkeley , California
Posted:
October 16, 2017
Reference:
50365701
Your tasks and responsibilities
The primary responsibilities of this role, Specialist Product Failure Analysis Lab, are to:

  • Conduct examination and investigations on marketed drug product technical complaint samples (global and including clinical samples) and other partner product samples as needed;
  • Analyze samples from production to support investigations;
  • Production samples can range from raw materials to final container to samples taken at various process steps;
  • Be able to run Scanning Electron Microscope with Energy Dispersive X-Ray Analysis and FTIR instrumentation, stereoscopes and digital microscopes;
  • Work with QA business partners in conducting customer complaint investigations;
  • Work with Manufacturing Sciences, Global Biologics Development and other internal customers from various functions in support of production issues;
  • Be able to work with limited supervision or no guidance;
  • Be able to generate data at short notice and manage rush samples which may require doing what is essential and value added, re-prioritizing and sometimes needing longer hours;
  • Evaluate data generated and write and review final reports and memos for customer product technical complaints and production sample analysis;
  • Responsible for archiving reports;
  • Track, receive and manage samples from customer product complaints;
  • Serve as an SME on product technical complaints and various production samples;
  • Serve as a technical resource to laboratory staff and cross functional areas;
  • Contribute to the overall health and growth of the lab;
  • Write SOPs, job safety analysis, templates, etc. Train others;
  • Share knowledge cross functionally, as needed, through presentations, demonstrations, etc.;
  • Be trained and compliant; be committed to quality and safety by complying with cGMP, health and safety requirements and environment protection initiatives;
  • Be a leader, be proactive, self-motivated, flexible, a team player and keen learner;
  • Work on assignments that can range from simple to complex in nature;
  • Judgment is required in resolving problems and making recommendations;
  • Normally receive minimal instruction and support on assigned work.


Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

  • Bachelor's Degree in Science or technical field;
  • Minimum 6 years of experience in pharmaceutical or related industry or an equivalent combination of education and experience;
  • Knowledge of cGMP, detail oriented;
  • Experience with analytical methods preferably in a biopharmaceutical, pharmaceutical or device industry;
  • Prior knowledge in analyzing customer complaints and production samples is a plus;
  • Experience with Scanning Electron Microscope with Energy Dispersive X-Ray Analysis;
  • Experience with digital optical microscope and FTIR Spectrometer with Continuum FTIR Microscope;
  • Experience with Stereoscopes with Digital Camera and SLR Digital Camera;
  • Good project management and organizational skills; technical writing and communication skills;
  • Knowledge in deviation management;
  • Good people skills - ability to influence and negotiate.

Preferred Qualifications:

  • Master's Degree (M.S.) or Ph.D. in a Science or technical field such as Materials Science or Engineering, Chemistry or Chemical Engineering.


Your application
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans
 
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
 

Country: United States
Location: CA-Berkeley

A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.

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