Role Summary

The qualified candidate must have the experience and ability to participate in multiple projects within the Quality Facilities, Utilities and Raw Materials testing group and Quality Control Microbiology group. This individual should be able to coordinate and support the different testing activities in the lab and equipment issues used by the team during the daily activities. This individual should be able to Independently troubleshoots all routine and some complex technical problems. 

Team Assays are performed in compliance with USP, FDA and other regulatory body requirements and per standard operating procedures. 

Role Responsibilities

• Performs all work in compliance with cGMPs and site requirements. 
• Recognizes atypical or out-of-specifications test results, instrument malfunctions and methodology problems and collaborate with the investigation to resolve and correct.
• Accountable for the accuracy and validity of testing results.  Responsible for ensuring all samples are tested within the appropriate timeframes and that data is reviewed in accordance to site procedures.    
• Trains less experienced analysts in new and existing procedures, techniques, and governmental regulations.  Mentors analysts by providing technical knowledge and support in resolving technical problems. 
• Oversees and ensures that laboratory work area is maintained in a neat, orderly, and compliant manner.  Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.

This candidate will be responsible for performing bioburden (membrane filtration and rapid ScanRDI) and endotoxin testing on water samples and raw material samples. This role also involves total organic carbon (TOC) testing, conductivity as needed.

Qualifications

• MS in Microbiology or related field with 6+ years of industry experience, preferably in the biopharmaceutical industry, or BS in Microbiology or related field with 10+ years of industry experience, preferably in the biopharmaceutical industry

• Extensive knowledge and practical application of relevant techniques – particularly TOC, Scan RDI (or other rapid bioburden technologies) endotoxin and membrane filtration bioburden and classical microbiology techniques.   Demonstrated ability to analyze the different assays results data.
• This person should have experience in Environmental Monitoring with an understanding of compendial requirements.
• Demonstrated ability to independently develop, document, validate, and troubleshoot methods of high levels of complexity.

• Proficiency with MS Word, Excel, LWLIMS and MODA
• cGMP experience is a plus but not required

 Must-Have

• Bachelor's Degree
•  6+ years' experience
• Demonstrated experience in industrial and/or aseptic pharmaceutical production environment, technical knowledge of aseptic processing and sanitization
• Demonstrated independent accomplishment of complex analytical method development and validation
• Ability to receive feedback and takes accountability for actions and personal development
• Excellent effective written and verbal communication and interpersonal skills
• Basic computer skills, such as data entry, with a high level of attention to detail, are also required

• Position is a mixture of lab and office, approximately 50-75% of the time will be spent in the laboratory.  Occasional weekend and holidays work may be required.

Nice-to-Have

• Experience leading continuous improvement projects
• Experience defending laboratory practices in regulatory audit.
• Working knowledge of organic chemistry, including degradation mechanisms of pharmaceutical active ingredients and pharmaceutical products

  
  Last Date to Apply: November 14 2022

Relocation assistance may be available based on business needs and/or eligibility.