QC Microbiologist Associate (Bioburden)

Payrate: $35.00 - $37.00/hr.
 
Summary:
The PD Associate will work collaboratively with a team of scientists to execute studies supporting microbiological method development, optimization, and troubleshooting. The role will primarily focus on laboratory execution while also contributing to study design, data analysis, as well as support scientists in drafting protocols/summary reports. Activities also include the evaluation of new technologies/rapid microbiology methods (RMM).
 
Responsibilities:

• The successful candidate will perform studies independently and collaborate with scientists on study execution, support team on data analysis and drafting of protocols/summary reports. In addition, the PD Associate will interface with QC and other cross-functional partners and represent the Process Microbiology team in scientific and technical discussions.
• Responsibilities:
• Execute laboratory studies supporting microbiological method development, optimization, troubleshooting, validation including (but not limited to):
• Endotoxin method/low endotoxin recovery (LER) studies
• Microbial Challenge/Hold time studies
• Bacterial Retention Testing/Sterile Filtration Studies
• Advancement of existing methods and implementation of alternative technologies, such as recombinant reagents for endotoxin testing and Monocyte Activation Test (MAT) for pyrogen testing
• Evaluation of RMMs
• Analyze and interpret experimental data, summarize study results, and assist with the preparation of protocols, technical assessments, reports
• Maintain knowledge of current compendial and regulatory requirements applicable to microbiological testing and microbial control, including USP, Ph. Eur., JP, and relevant regulatory guidance (Annex 1, CFRs, etc.)
• Collaborate with QC Microbiology, Process Development, Manufacturing, Quality and other functions to support the  network
• Participate in and represent Process Microbiology in scientific and cross-functional meetings, including communicating study progress, study results, and technical findings
• Communicate effectively and efficiently with cross-functional team members, clients, and partner organizations
• Support day-to-day laboratory operations, including maintaining laboratory supplies and inventory, coordinating ordering of materials, and ensuring appropriate supplies are available to support study execution

 
Basic Qualifications:

• Bachelor’s degree and 2 years microbiology, related biological science experience

 
Preferred Qualifications:

• Hands-on experience in microbiology and aseptic techniques.
• Prior experience in Microbiological Quality Lab or similar microbiology laboratory environment
• Demonstrate the ability to understand, apply, and evaluate microbiological principles
• Experience with compendial microbiological methods, including bioburden, bacterial endotoxins, and/or sterility testing
• Detail-oriented with strong laboratory documentation and technical writing skills.
• Ability to independently organize and execute laboratory studies while effectively managing multiple priorities and timelines
• Effective written and verbal communication skills with the ability to work independently as well as collaboratively in cross-functional teams
• Proficiency with tools used to organize and manage projects and data, such as SharePoint and Smartsheet

 
Top 3 Must Have Skill Sets:

• Experience in a QC Micro Lab;
• Knowledge of compendial methods for Bioburden
• Sterility and Endotoxin (USP/EP/JP)
• Hands on testing experience.

 
 
Pay Transparency: The typical base pay for this role across the U.S. is: $35.00 - $37.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 

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