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R&D Microbiologist

Department: Microbiology
Location: West Columbia, SC

Position Summary:

  • Performs research and develops projects for established products and new products including but not limited to microbiological test method validation/transfer/verification, procedures, investigations, and other non-specified projects or initiatives.
  • Plans, organizes, and manages resources on projects to assure technical quality and schedule adherence.
  • Performs other duties as assigned or apparent. 

Primary Accountabilities:

  • Capable of working in a GMP environment and responsible for generating GMP data.
  • Capable of working with different microbiological techniques and equipment including but not limited to gram stain, turbidimetric endotoxin testing, liquid particle counter, isolator, bioburden filtration analysis, sterility testing, aseptic process simulation, and MALDI-TOF.
  • Responsible for performing different microbiological tests for Research & Development and Quality Control as needed.
  • Responsible for performing investigations related to environmental monitoring and laboratory testing.
  • Responsible for executing research and test method development projects for established and new products.
  • Assist in drafting Research & Development and Quality Control protocols and summary reports.
  • Participates in the development and implementation of associated programs (e.g. cleaning validation, process validation, GMP compliance, equipment validation, maintenance and use, etc.)
  • Oversee and ensure reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities (i.e. FDA)
  • Assist in generating trending reports for clean room environments.

 

NOTE: The primary accountabilities above and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbentsí performance objectives as outlined by the incumbentsí immediate supervisor or manager.

Knowledge, Skills & Abilities:

  • Regionally accredited Masterís Degree in Biology and/or a minimum of 3 - 5 years of previous experience in cGMP related environment preferred.
  • Highly skilled in conducting microbiological analysis such as identification, morphological analysis, endotoxin testing, and etc., needing little or no guidance.
  • Strong interpersonal, verbal, and written communication skills.  Effective organization, multi-tasking, and problem solving skills.
  • Computer experience (Microsoft Word, Excel, Power Point)
  • Specific expertise, skills and knowledge within research, product development, gained through education and/or experience.
  • The ability and willingness to change direction and focus to meet shifting organizational and business demands.
  • The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
  • Possesses the initiative and follow through to implement, track and achieve on-time completion of projects, as assigned by management.
  • Must strive for continuous improvement in all work activities.
  • The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.

 

  • Position requires typing, climbing, lifting (up to 15lbs), reaching, vision (20/20), standing (10%), sitting (90%), walking, and hearing
  • Additional Requirements:  As needed
  • Salary range: Based on experience

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