Development Scientist - Microbiologist
Hiring By - Biostaffic
BioPharma
Wichita, Kansas - United States
Job Highlights
Not Disclosed
Mid-Senior level
Posted 9 months ago
Job details
About The Job
The Development Scientist - Microbiologist will support the development/validations of methods for the commercial release of new products.
Role And Responsibilities
Profile/Experience
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
The Development Scientist - Microbiologist will support the development/validations of methods for the commercial release of new products.
Role And Responsibilities
- Work within a cross functional team to support microbiology method development/validations for the release of new products
- Provide scientific guidance on the production of complex new products
- Review and draft documents such as protocols, reports and procedures in accordance with regulatory and USP compliance
- Execute scientific protocols independently
- Perform testing and/or develop analytical methods such as, but not limited to:
- Bacterial Endotoxin
- Bioburden
- Particulate matter
- Sterility
- Train laboratory staff on new methods
- Remain current on all relevant training
- Adhere to lab policies pertaining to safety and cleanliness
Profile/Experience
- A bachelor’s degree in a science field and 4+ years experience in pharmaceutical quality control and/or research and development. (graduate school may be considered toward experience)
- Working knowledge of Current Good Manufacturing Practices and appropriate sections of CFR 210 and 211
- Basic typing, computer and office skills
- Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirements
- Excellent interpersonal communication and organizational skills
- Qualified to work with controlled substances
- Experience Handling Biohazardous materials
- Knowledge of analytical support activities for production support and validations
- Ability to conduct OOS investigations with lab management and other functional areas
- Ability to perform method development activities independently
- Ability to establish priorities, work independently and proceed with objectives without supervision
- Ability to manage project work while managing daily duties and completing all on time
- Ability to adapt to new or updated processes
- Ability to work with a variety of lab equipment such as would be used for above listed responsibilities
- Ability to troubleshoot problems with analytical equipment and perform or suggest appropriate actions
- Ability to write and execute design of experiments for development and investigations
- Consult with other functional areas with regards to investigations, validation studies, production technical issues, etc.
- Ability to work with team members and other departments to accomplish goals
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Location:
- Wichita, Kansas - United States
Experience:
- Mid-Senior level
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 12, 2024
Company Overview
Fagron
Current Openings: 0
Fagron is committed to the personalization of health treatment to cover the individual patient’s need through Pharmaceutical Compounding & Sterile Outsourcing Services. Pharmaceutical Compounding allows pharmacists and prescribers to create medication that satisfies patients’ needs. Through our services towards personalization, we can extend the range of mass-produced medication and keep available medicaments that are no longer offered commercially in an affordable way for those who need them. Fagron was founded in the Netherlands in 1990 and is currently present in 35 countries worldwide enabling pharmacists, prescribers, hospitals, and industry to provide quality, safety, and service for their patients. Together we create the future of personalizing medicine.
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