GMP Manufacturing Associate II, Downstream

Req ID #:  141772
Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20850 Rockville, MD, US, 20852

For 70 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.


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. 

Job Summary

 

The GMP Manufacturing Associate II, Downstream 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 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.
 

Job Qualifications

 


· High School Diploma or Associate Degree with 3-7 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 2-4 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.

· Attention to detail and time management.

· Previous work in viral or vaccine production highly desired.

· 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.
 

 

Working Conditions

 

· Operations are 24 hours per day, 7 days per week, and shift work will be required.

· Must be able to gown and pass gowning qualification to work inside a cleanroom for at least 4 consecutive hours.

· Must be able to work flexible hours – must be willing to work outside of normally-scheduled hours as necessary.

· Must have reliable transportation to travel between sites in Rockville area.

· Standing, (sometimes prolong standing), sitting, pushing, pulling, walking, bending, stooping, kneeling, and must be able to lift up to 50 lbs.

 

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 


Vaccine Mandate
Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 


Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 18,000 employees within 100 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 supported the development of >80% of the drugs approved by the FDA for the past 3 years.


Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.


 
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: Washington DC

Job Segment: Biotech, Biology, Pharmaceutical, Laboratory, Science, Research