Scientist II - Method Development
Charleston, SC, US, 29407
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Overview
Primarily responsible for study design and method development of highly complex Alternative Microbiological Method validations. Serves as a technical subject matter expert related to QC Microbiology and regulatory requirements for sterility and microbial release testing. Performs microbiological testing that requires excellent aseptic technique and critical thinking. Is experienced in technical writing as it relates to data compilation, protocol design, and laboratory investigations. Capable of providing and justifiying technical recommendations to study design. Assists with customer support activities such as sample receipt, materials QC testing, and occasional direct communication with customers. Effectively collaborates with other team members to perform all required laboratory tasks.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Understands and applies regulatory requirements when writing and executing protocols for validation projects.
• Provides design criteria and technical recommendations for highly complex studies.
• Completes bacteriologic analysis utilizing varying instrument platforms and laboratory testing procedures; samples can include raw materials, pharmaceutical drugs, or cell cultures.
• Performs advanced technical skills such as deriving low inoculum counts from environmental isolates, revival of spores or other bacterial cultures, and maintaining aseptic technique while performing highly manipulative test methods.
• Proactively completes all assigned tasks in an organized and well-considered manner.
• Allocates time efficiently to meet overlapping deadlines and laboratory goals.
• Troubleshoots technical difficulties encountered during study execution with little oversight.
• Assists in continued method development of internal testing procedures to include ruggedness and robustness studies.
• Comply with SOPs, SDS sheets, and laboratory procedures to ensure the integrity of our data.
• Maintain records compliance by adhering to regulatory guidelines set forth by the company and varying agencies.
• Identifies and completes any required laboratory investigations or unplanned deviations using specified quality assurance platform with little oversight.
• Assists coworkers in the completion of all laboratory maintenance activities.
• Perform all other related duties as assigned
Qualifications
- Education: Bachelor’s Degree in a Biological Sciences discipline with at least some coursework directly related to Microbiology. Master’s Degree preferred.
- Experience: 5-10 years industrial microbiological experience with Bachelor’s Degree, 0-5 years industrial microbiological experience with Master’s Degree
Note: ‘years industrial microbiological experience’ is considered years working in applicable industrial laboratories only, such as foods, consumer products, or pharmaceutical microbiology. Clinical microbiology experience is not considered.
- Certifications/Licensures: None
- Proven ability to demonstrate accountability and collaborate effectively with coworkers
- High standards for integrity and quality of work performed
- Demonstrated experience of independently developing new processes and procedures from conception to implementation
- Extensive experience in statistical analysis
The pay range for this position is $70k-85k. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
Nearest Major Market: Charleston South Carolina
Nearest Secondary Market: South Carolina
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