GMP, Manufacturing Associate II, Downstream (CDMO)
At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.
Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.
As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Position Title: Downstream GMP Manufacturing Associate II ( CDMO)
The Downstream GMP Manufacturing Associate II will work as part of a team and work directly in activities associated with purification that applies a broad knowledge of biological, bioprocess, and mechanical principles to execute complex operations that result in clinical and commercial stage medicines to dramatically improve the human condition through gene therapy. The activities will take place in a cleanroom following aseptic techniques and procedures in a cGMP environment.
Duties and Responsibilities
• Perform Downstream purification activities such as Chromatography, Tangential flow filtration (TFF), Ultracentrifugation, and Final Formulation steps. • Work in cleanroom environment while adhering to Standard Operating Procedures (SOPs). • Prepare, sanitize, and disinfect equipment to prevent microbial contamination. • Monitor processes using automated production systems and controls with supervision. • Obtain and perform in-process sampling. • Prepare buffers and solutions needed for Downstream activities, including at at large scale (> 20L). • Perform various filter integrity tests throughout the process. • Document all activities in Batch Records, Logbooks, Forms, etc. • Follow verbal and written procedures in operating production equipment and performing processing steps; accurately complete appropriate production documentation. • Effectively communicate and interface with team to ensure the completion of daily activities. • Operate manual and semi-automated equipment in support of routine production with minimal supervision. • Edit and review Production Batch Records and Standard Operating Procedures. • Work in cleanroom environment while adhering to Standard Operating Procedures (SOPs). • Interact with other departments to complete activities associated with Downstream operations. • Perform other tasks as assigned to support GMP Manufacturing that ensures sustainable right-first-time performance.
• High School Diploma or Associate Degree with 3+ years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company; or • Bachelor of Science in science or Engineering and 2+ years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company. • Technical understanding of purification processes from cell culture processes. • Hands-on experience with chromatography systems (AKTA systems at different scales) and approaches (Affinity, IEX, MMC), TFF modalities, and single use mixing systems. • Ability to operate manual and semi-automated equipment in support of routine production with minimal supervision. • Experience in the preparation of buffers at large scale (≥ 20L). • Experience editing and reviewing Production Batch Records and Standard Operating Procedures. • Organizational and planning skills. • Ability to work in a Team and collaborative environment. • Previous work in viral or vaccine production preferred. • Previous experience working for a Contract Manufacturing Organization (CMO) preferred. • Communication skills (writing, speaking, comprehending). • Basic computer skills including Microsoft (Word, Excel, Teams etc.). • Ability to work in a fast-paced environments.
This position is located at our Rockville, MD site ( Shady Grove area)
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