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Supervisor, Quality Control, Microbiology (Night Shift)

Philadelphia, PA 19112

Posted: 12/12/2024 Employment Type: Direct Hire/Perm Job Category: Scientific Job Number: 616644 Is job remote?: No Country: United States

Job Description


The Supervisor, Microbiology supports the environmental monitoring and microbiology testing programs. This is a working Supervisor role and responsible for overseeing the routine operations and perform testing such as sterility testing, endotoxin testing, media growth promotion, environmental monitoring, plate reading, data review, microbiology investigations, and other microbiology methods as needed to support product release. This position also assists in site and method qualification, validation and commissioning activities. This position works closely with contract labs and vendors to manage outsourced testing.

 

Shift
  • Tuesday - Friday from 5pm - 3:30am

 

Essential Functions and Responsibilities

 
  • Oversee day to day operations in the QC Microbiology laboratory in support of environmental monitoring and batch related microbiology testing on the weekend shift.
  • Perform daily cGMP quality control laboratory microbiological testing activities and environmental monitoring of the cleanroom areas at the facility as required.
  • Schedule and perform routine gas sampling at the facility as required.
  • Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
  • Oversee growth promotion testing of microbiological media using both ATCC and in-house isolates.
  • Oversee environmental monitoring of the manufacturing areas, including batch related EM, is performed accurately and according to the manufacturing schedule.
  • Ensure all in-process and lot release microbiology testing is performed and reviewed accurately and timely.
  • Ensure timely review of routine environmental monitoring data, microbiology testing data, and excursions and OOS reports are completed accurately and timely.
  • Work closely with contract labs to ensure that samples are submitted and tested in a timely manner.
  • Ensure gowning qualifications and re-qualifications for personnel needing access to classified manufacturing areas is performed, tracked, and trended.
  • Draft and execute protocols in support of site contamination control programs, as needed.
  • Oversee the maintenance and built of a microbial identification database for all in-house isolates recovered from the various monitoring programs.
  • Work closely with Sterility assurance team to ensure trend analysis and trend reports for environmental monitoring data are performed timely.
  • Support site qualification/validation/commissioning activities as needed.
  • Serve as a qualified trainer, provides guidance to other analysts.
  • Initiate and investigate deviations.
  • Mentor and support career development of direct reports.
  • Support audits and inspections as needed.
  • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
  • Perform miscellaneous duties as assigned.

 

Required Education, Skills, and Knowledge

 
  • Bachelor’s degree in Biology, Microbiology or related scientific field is required
  • Minimum five (5) years of experience in in a cGMP Quality Control microbiology role
  • Prior experience in managing a team and having direct reports.
  • Basic knowledge of Compendial (e.g., USP, EP, JP, ) requirements and standards
  • High proficiency in aseptic techniques when executing microbial test methods and environmental monitoring
  • Proficient in performing technical writing (e.g., test methods, SOP's, protocols, )
  • Strong technical writer with experience in writing protocols, deviations, investigations, SOPs
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
  • High level of ownership and accountability

 

Preferred Education, Skills, and Knowledge
  • Experience with cell therapy products is a plus

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Philadelphia, PA

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.