Technician I Bioassay

Charles River Laboratories; Wayne (PA); On-site; USD 27,000 - 39,000; Full time

Job summary

Charles River Laboratories in Wayne, PA seeks an entry-level Bioassay Technician to perform routine bioassay methods under SOPs and client methods. You will prepare reagents, maintain the lab, analyze data and generate routine CGMP and R&D reports, while updating sample-tracking databases and maintaining inventory.

Strong documentation habits are essential. Ideal candidates have a Bachelor's in biochemistry/biology/chemistry and 0–1 year in analytical science, with basic knowledge of aseptic

Qualifications

• Bachelor's degree in biochemistry, biology, chemistry or related discipline.
• 0–1 year of experience in analytical science within pharma/biotech/CRO lab environments.
• Knowledge of cGMPs or regulatory affairs is preferred; basic aseptic techniques and cell culture knowledge; basic bioassays such as ELISA.

Responsibilities

• Perform bioassay methods under SOPs and client test methods.
• Reagent preparation and lab maintenance.
• Data analysis for routine procedures and generation of CGMP/R&D reports.
• Update sample-tracking databases and manage chemical inventory.
• Maintain accurate documentation and perform peer data reviews.
• Ensure compliance with regulatory standards and safety policies.

Skills

Attention to detail

Organizational skills

Interpersonal skills

Communication

Team collaboration

Education

Bachelor's degree in biochemistry/biology/chemistry

Tools

LIMS

Microsoft Office

Job description

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

Under direct supervision, perform bioassay methods as specified in standard in-house SOPs and Client Test Methods and other written procedures.

Essential Duties And Responsibilities

• Independently perform laboratory activities including but not limited to:
• Reagent preparation
• Laboratory maintenance / monitoring
• Equipment maintenance / monitoring
• Preparation and routine testing of client samples
• Data Analysis for routine procedures
• Generation of routine cGMP and R&D reports.
• Develop understanding of processes and procedures used within the Bioassay department with a specific focus on Routine Testing. This includes understanding of sample type, purpose of test selection, necessary supplies and documentation expectations as well as developing the ability to trouble shoot and problem solve with scientific guidance.
• Update sample-tracking databases
• Maintain chemical inventory for the laboratory.
• Develop and maintain excellent single and multichannel pipetting skills.
• Competently perform peer review of data
• For cGMP and R&D routine testing, generate analytical data and technical report(s) on-time with respect to internal and client deadlines. Maintain a weekly schedule to ensure all timelines are met.
• Maintain a safe working environment by adhering to company policies and procedures. Actively participate in laboratory maintenance.
• Comply with all pertinent regulatory standards regarding environs, equipment and testing services.
• Make detailed observations and maintain clear, detailed, accurate and timely documentation of all laboratory work.
• Compose high quality documentation including deviation reports and change control documentation under guidance.
• Follow all SOPs, STMs, CTMs, and cGMP guidelines as they relate to specific tasks.
• Maintain up to date training records on all procedures and protocols applicable to work duties.
• Ability to work in a structured and regulated environment
• Work productively in group situations as well as independently
• Perform all other related duties as assigned.

Qualifications

• Education: Bachelor’s degree (B.S.) or equivalent in biochemistry, biology, chemistry or related discipline.
• Experience: 0 to 1 years related industry experience in an analytical science area in the Pharmaceutical, Biotech or contract (CRO) laboratory environment.
• Certification/Licensure: None
• Other: Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred. Knowledge of basic aseptic techniques and cell culture. Basic knowledge of bioassays (e.g. ELISA, cell-based assays) is encouraged. Strong organizational and prioritization skills required. Attention to detail and accuracy a must. Must possess excellent interpersonal skills to maintain communication across functional groups. Ability to collaborate effectively within a group environment. Able to communicate effectively (verbal and written) in a small group or one on one setting. Basic Microsoft Office skills are required. Ability to understand and use internal software programs such as LIMS required.

Pay

The pay for this position is $24.00 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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 over 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.

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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past 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 is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

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 [e-mail]. 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.