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Supervisor, QC Microbiology at EBSI

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Baltimore, Maryland





Job Description:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.


















I: Job Summary

Supervise and organize microbiologists in sampling, testing and documentation environmental monitoring and product testing programs per cGMP and SOPs.  These activities may include but not be limited to: contact plates, personnel monitoring, SMA/SAS, settling plates, and total particulate monitoring during fill processes, routine monitoring, and sterility suite monitoring.

II: Responsibilities


  • Supervise operational activities of laboratory personnel in an organized and efficient manner to prevent any delays in product release.

  • Assist Microbiology Manager with all day-to-day production issues as they arise.

  • Perform trend analysis for batch record turn around, deviations and OOS investigations.

  • Implement quality improvement initiatives and corrective actions.

  • Conduct microbiological qualitative and quantitative analyses of samples.

  • Investigate, suggest, validate and implement new laboratory procedures/techniques.

  • Provides expertise and troubleshoots microbiology related issues.

  • Review and approve SOP and validation protocols as related to Microbiology.

  • Review record keeping and documentation of laboratory equipment maintenance.

  • Review and update existing techniques, specifications, testing standards and SOPs or write new documents.

  • Supervise and provide significant contribution to the development and implementation of cGMP and GLP.

  • Document all procedures and results.

  • Represent department in meetings with Production, QA/RA, Engineering and other related departments.

  • Advise, recommend, and implement resolutions for quality issues and non-compliance.

  • Maintain database of laboratory data tracking and trending.

  • Ensure that all equipment is fully calibrated and validated.

  • Assist in reviewing QC Batch Records before submission to QA.

  • Initiate OOS investigations for Final Product, In-Process, Stability and other cGMP data.

  • Assist Method Validation in validation report generation and review.

  • Identify and recommend equipment, supplies and vendors for microbial analyses.

  • Guide the professional development of supporting staff both as individual and as a group.

  • Evaluate the performance of assigned staff and recommend salary increases, promotions and disciplinary actions.

  • Participate in interviewing process for hiring supporting staff.

  • Participate and attend professional seminars, conferences and conventions

 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

III: Education, Experience & Skills


  • B.S. in Microbiology/Biology or related field with a minimum of 8 years experience in the Pharmaceutical or Biotechnology industry and 2 years experience in a supervisory/leadership role. OR an M.S. with minimum of 5 years experience including 1 year in supervisory/leadership role.

  • Emphasis in aseptic processing, QC microbiology, environmental monitoring, water systems, quality control, validation and manufacturing processes is essential.


  • Must have previous hands-on experience with microbiological methods such as Bacteriostasis and Fungistasis, Enhancement and Inhibition, LAL, Sterility, Bioburden Testing.

  • Competent in the use of various computer programs of MS Access and Excel.

  • Excellent communication, documentation and organizational skills.

  • General knowledge of FDA regulations pertaining to cGMP’s.

 

IV: Physical/Mental Requirements

Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell,  lift/carry ___ lbs, and pull ___ lbs.  Use phone, fax, copier, and computer.  Use hand tools and operate fork lift. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents.  Drive automatic/standard vehicle. Work outdoors, around noise above conversation level, in hot/cold temperatures, in high humidity, where ventilation is needed, in multiple locations, with restricted access to laboratory, in contact with Select Agents, and with exposure to animals, animal areas, or equipment used in animal areas.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.