Biomanufacturing Associate I

Company: Charles River Laboratories, Research Models and Se
Location: Rockville
Posted on: November 20, 2022

Job Description:

Press Tab to Move to Skip to Content Link 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 I will play an integral role within CRL's gene therapy manufacturing function by understanding and applying biological, bioprocess, manufacturing, and mechanical principles, processes, procedures, inputs, and outputs, 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. - This role will perform a range of routine and semi-routine tasks, some of which are moderately difficult, requiring judgment in resolving issues or making recommendations, with guidance as needed, in order to proficiently execute manufacturing protocols in a regulated environment. - ESSENTIAL DUTIES AND RESPONSIBILITIES: -
--- Under guidance, apply and adhere to SOPs, cGMP, GLP, Quality, and basic Safety standards and requirements when completing tasks.
--- Perform a range of routine and semi-routine tasks, in accordance with SOPs, under guidance, in one of the following areas:
o Basic Upstream Activities (e.g., assist with 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). -
o Basic Downstream Activities (e.g., assist with cell lysis, chromatography purification, centrifugation, Tangential Flow Filtration (TFF), and final formulation steps). -
o Basic Fill-Finish Activities (e.g., assist with buffers and solutions filling, capping, labeling, gathering, and preparation of equipment and materials for final drug product). -
--- Follow verbal and written instructions (e.g., SOPs), when performing planned manufacturing activities, in alignment with the batch record, and under guidance.
--- With guidance, use basic quality documents and apply Good Documentation Practices.
--- Ensure data integrity by accurately documenting, reviewing, and correcting work prior to submission. -
--- Identify, record, and report observed process variances and deviations in real time. -
--- Apply and adhere to SOPs, safety guidelines, and manufacturing instructions when completing process tasks and when operating equipment. Prepare, clean, maintain, and operate equipment and tools. -
--- Recognize common safety issues and report all injuries and safety incidents immediately.
--- Adhere to safe working practices and comply with site-based guidelines to avoid the consequences of error by applying: -
o Cleanroom and aseptic behaviors and procedures. -
o Proper Personal Protective Equipment (PPE) and gowning requirements. -
o Proper preparation, disinfection, sterilization, and sanitation methods and processes for equipment, etc. -
o The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials.
o Universal precautions with respect to OSHA guidelines. -
--- 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: 2 years of related experience with a High School Diploma. 1 year of related experience with an Associates degree. 0-1 year of related experience with a Bachelors degree. Related experience may include prior experience in a technical role and/or within a cGMP and/or biotech manufacturing environment or other related industry, etc. -
--- Other:
--- Able to work in accordance with the Charles River Values. -
--- Willing and able to continuously learn and improve.
--- Strong attention to detail and ability to recognize deviations from accepted practices.
--- Good documentation and GDP skills.
--- Working knowledge of computer software (MS Word, MS Excel, Teams, database systems, etc.). - 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, Testing, Chemical Research, Laboratory, Scientific, Science, Technology, Engineering

Keywords: Charles River Laboratories, Research Models and Se, Rockville , Biomanufacturing Associate I, Other , Rockville, Maryland