EmployIndy
  • Immediate Opportunities - Life Sciences
  • Indianapolis, IN, USA
  • Full Time
  • Full package of benefits

QC Microbiology Analyst II / III – Exelead (Depending on Experience)

EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis.  Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking candidates for QC Microbiology Analyst II / III. 

QC Microbiology Analyst II

Major Position Activities & Responsibilities:

  • May be required to perform environmental monitoring in support of commercial filling activities and routine environmental monitoring program.
  • May be required to perform endotoxin, identification, bioburden assays on in-process and raw materials (including water).
  • May be required to perform preservative effectiveness, sterility, endotoxin, particulates etc. testing on finished products.
  • Write, review, and execute microbiology protocols in support of environmental qualifications, experimental studies, and method revalidation activities, when required.
  • Performs media fill testing in support of Manufacturing and Environmental Monitoring programs.
  • Technically train other EM analysts when required.
  • Performs EM data review and trending data entry.
  • Handling of wastes including hazardous wastes. Attendance at mandatory annual hazardous waste training meeting(s). Demonstration of competency in training by passing test(s) administered by the company or consultant providing such training.
  • Responsible for adhering to the Environmental, Health and Safety program.
  • Performs special projects and other duties as assigned.
  • As a part of the employee's job requirements, the employee may be required to handle wastes including hazardous wastes.  The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
  • With guidance, writes/reviews/ and edits ACM, ICM and SOP documents.
  • Provide Microbiology support for Manufacturing and Validation activities.

Scope:

  • 60% Environmental monitoring, 20% raw material, in-process, and finished product testing
  • or
  • 20% Environmental monitoring, 60% raw material, in-process, and finished product testing
  • 10% Training lesser experienced analysts
  • 10% Execution of selected projects as directed my Microbiology manager 

Background Qualifications:

  • Bachelor's degree in the biological sciences (BS) and 1-3 years related experience with a QC Microbiology laboratory in a pharmaceutical company, or equivalent combination of education and training.
  • Strong technical knowledge of analytical and microbiological techniques.
  • Ability to gown aseptically for Manufacturing and Aseptic Filling areas.
  • Must be able to strictly follow written procedures. Excellent documentation skills and note taking are a must-have skill. 
  • Familiarity with scientific method is a requirement. Ability to design and execute environmental excursion investigations is required.
  • ability to communicate at all levels in a pharmaceutical organization.  Excellent interpersonal skills are a must.

 

 

QC Microbiology Analyst III

Position Overview:

This position is a senior technical position within the Microbiology department responsible for microbiology testing, microbiology data review, performing investigations, execution of protocols and training lesser experienced analysts.

 Major Position Activities & Responsibilities:

  • Technical training of lesser experienced microbiology personnel on procedures and systems.
  • May be required to perform endotoxin, identification, bioburden assays on in-process and raw materials (including water).
  • May be required to perform preservative effectiveness, sterility, endotoxin, particulates etc. testing on finished products.
  • Develop and supervise the execution of protocols for method transfers, method validations, stability studies, and cleaning validations.
  • Develop and supervise special studies/projects applicable to the Microbiology and Chemistry Laboratories.
  • Review Analytical and Microbiology testing procedures and test data
  • Represent QC department as technical expert on special studies and validations when required.
  • Responsible for project managing assigned QC capital projects.
  • Support manufacturing process control & process improvement projects
  • As a part of the employee's job requirements, the employee may be required to handle wastes including hazardous wastes.  And, the employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
  • Responsible for adhering to the Environmental, Health and Safety program.
  • Performs special projects and other duties as assigned.
  • As a part of the employee's job requirements, the employee may be required to handle wastes including hazardous wastes.  The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training. 

Scope:

  • 10% Training of junior analysts
  • 40% Execution of selected projects as directed by the Microbiology manager
  • 50% Individual contributor as bench analysts and technically training and assisting microbiology junior personnel

 Background Qualifications:

  • BS (MS preferred) in Biology, Microbiology or related discipline with minimum 4 years experience in the pharmaceutical industry, or equivalent combination of education and training.
  • Strong technical knowledge of analytical and microbiological techniques.
  • Must have solid cGMP expertise in testing/manufacturing environments.
  • Experienced in methodology required for method validations, experienced in scientific research. 
  • Ability to communicate at all levels in a pharmaceutical organization.  Good interpersonal skills are a must.
  • Ability to perform functions as itemized in physical and environmental requirements of the job, which will include travel to vendors or contract laboratories as required.
  • Ability to trouble-shoot and find the root cause for laboratory failures is required.  Ability to design an investigation plan, execute, summarize, and propose corrective actions for environmental excursion investigations is also required.

 




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