Microbiologist

  • location: Norwood, MA
  • type: Contract
  • salary: $34.82 - $40.87 per hour

job description

Microbiologist

Chat with me now! - https://flashrecruit.com/jobs/301587

Job Title: Senior Associate, QC Microbiology

Job Summary

  • Reporting to the Senior Manager of Quality Control (Microbiology), the Quality Control Microbiology Senior Associate will support microbiological method transfer, qualification and release testing for GMP QC raw materials, excipients, drug substance and finished product testing for mRNA products produced at te company's manufacturing facility and affiliated contract organizations.
  • He/she will contribute to the implementation of QC Microbiology testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting.
  • This position will have a primary focus in supporting Quality Control testing in association with the Company's Personal Vaccine Unit (PVU).
  • The position may require off-shift hours including nights and weekend.

Job Responsibilities

  • Collaborate with development groups for method transfers and qualifications in support of expanding the GMP QC Microbiology laboratory capabilities to include: Rapid Sterility, Rapid Bioburden, Endotoxin, Culture Purity and Cell Stock Identity, Cell Density Determination, TOC and Conductivity Testing utilizing both standard and rapid methods.
  • Support testing for raw materials, intermediates, drug substance and drug product, including generation of testing data to support clinical studies
  • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Assist with equipment qualification / validation activities, including maintenance
  • Troubleshoot issues related to equipment, laboratory procedures and assay performance
  • Conduct technical assessments of deviations and investigations
  • Write/revise SOPs, technical protocols and reports
  • Offer input and suggestions for improvement in laboratory operations and procedures
  • Train and provide technical guidance to other microbiologists

Education & Qualifications

  • BS in a relevant scientific discipline with a minimum of 2-5 years (or MS in a relevant scientific discipline with 0-2 years) Quality Control experience in a cGMP organization with a focus in Microbiology
  • Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
  • Expertise with Vitek®, MicroSEQ® Rapid Identification Systems, Rapid Microbiology Systems and Isolator Technology
  • Demonstrated knowledge of method development and qualifications
  • Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
  • Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Excellent communication skills (verbal and written)

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/301587

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