Job Purpose: 

Microbiology R&D Analyst II 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. 

Essential Duties and Responsibilities:

· Provides support in development, drafting, and execution of investigations, method validations, and/or media fills.  

· Works 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.  

· Performs different microbiological tests for R&D Microbiology and QC Microbiology, as needed; also understands and performs routine investigations related to Environmental Monitoring and laboratory testing.  

· Works in a GMP environment and responsible for generating cGMP data.  

· Plans and executes research and test method development projects for both established and new products.  

· Participates in development and implementation of associated programs (e.g. cleaning validation, process validation, cGMP compliance, equipment validation, maintenance and use, etc.), as well as generating trending reports for cleanroom environments. 

· Participates in reading and documenting media fill results.  

· Works in a cGMP environment and is responsible for generating cGMP data.  

· Ensures reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities (i.e. FDA). 

· Assists in drafting R&D and QC protocols, summary reports, and studies.  

· Communicates Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to R&D Microbiology Manager, Assistant Director of Microbiology, Director of Microbiology, or designee.  

Supplemental Functions:  

• Performs other duties as assigned.

Knowledge & Skills: 

• Highly skilled in conducting microbiological analysis such as identification, morphological analysis, endotoxin testing, etc., with little to no guidance.  
• Strong understanding of general microbiological processes and testing; high level interpersonal, verbal, and written communication skills; and effective organization, multi-tasking, and problem solving skills. 
• Demonstrate the ability to perform all testing for the Quality Control portion of the Microbiology Lab. 
• Show proficiency in programs used by the Microbiology Lab such as LIMS and MODA. 
• Become certified to enter aseptic environments around the facility including ISO 5. 
• 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. 

Education/Experience: 

• Regionally accredited Bachelor’s degree in Microbiology or Biological Sciences required. 
• Master’s Degree in Microbiology and/or a minimum of 3 - 5 years of previous experience in cGMP related environment preferred. 

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), climbing, reaching, vision, hearing, standing, sitting and walking throughout the facility.