Biomanufacturing Associate II - Downstream

Req ID #:  204771
Location: 

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

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.

 

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 Biomanufacturing Associate II will play an integral role within CRL’s gene therapy manufacturing function by applying a solid knowledge of biological, bioprocess, manufacturing, and mechanical principles, processes, procedures, inputs, and outputs, equipment usage and applications and systems and technology principles for designated production processes and handovers within a cGMP and GLP environment. This will ensure the timely production and release of quality products, based on client specifications. The Associate II will apply solid knowledge and biomanufacturing experience when performing across a range of tasks, in resourceful and effective ways, requiring good judgment and initiative, when effectively executing manufacturing protocols in a regulated environment. 
 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 


•    Effectively apply and adhere to Standard Operating Procedures (SOPs), cGMP, GLP, Quality, and Safety standards and requirements (e.g., understand the value of Material Safety Data Sheets (MSDS) and identify and effectively apply the relevant information to work tasks) to ensure compliance. 
•    Effectively execute across a range of tasks, in accordance with SOPs and client specifications, in one of the following areas:
o    Upstream Activities (e.g., solutions, media aliquot, and buffer preparation and autoclave materials for cell culture, staging of raw materials, seed train, bioreactor set up, fermentation monitoring and/or harvest). 
•    Able to follow verbal and written instructions (e.g., SOPs), when accurately and effectively performing planned manufacturing activities, in alignment with the batch record including: 
o    Providing raw material and cell and gene culture preparation. Demonstrate a solid understanding when operating inside the Biological Safety Cabinet and aseptically perform cell thaw and passaging. 
o    Monitoring processes using manual, semi-automated, and automated production systems, and controls. 
o    Performing various filter integrity tests.
o    Preparing large scale (>20L) buffers and assisting others. 
o    Monitoring in-process analysis.
o    Ensuring proper data capturing, recording, and analysis.
o    Completing appropriate production documentation. 
o    Performing in-process and finished goods sampling (e.g., collecting and preparing) and inspections and forward to Quality. 
o    Supporting and maintaining SOPs and quality systems. 
o    Performing material transfer processes. 
•    Demonstrate a solid understanding of and use of quality documents (i.e., able to write cGMP, GLP documents and SOPs, and assist the Sr. BMA/Team Lead in accurately completing Batch Production Records (BPRs)). Well-versed in applying Good Documentation Practices (GDP) when accurately preparing/completing controlled working documents (i.e., initiating Non-Conformance Reports (NCRs), writing, and editing SOPs, and documenting Work Instructions (WI), Logbooks, and Forms) to comply with regulatory requirements. May observe GMP audits and/or support pre-work as part of the quality  learning process. 
•    Perform other responsibilities as required. 

Job Qualifications

 

•    Education:  High School Diploma or equivalent with high grades in science courses, or an Associates or Bachelors degree in biology/life sciences, bioengineering, or related discipline.
•    Experience: 3 years of related experience with a High School Diploma. 2.5 years of related experience with an Associates degree. 1.5 years of related experience with a Bachelors degree. Related experience will include prior cell/gene therapy experience in a technical role covering a range of tasks within a cGMP and/or biotech manufacturing environment or other related industry, etc.
•    Certification/Licensure:  If not qualified, is willing and able to become a qualified LEAN trainer in the near future.

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. 

 
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 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 86% of the drugs approved by the FDA in 2021.
 

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.

 
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: Pharmaceutical, Biology, Biotech, Cell Biology, Bioengineering, Science