What are the responsibilities and job description for the Biomanufacturing Associate II position at Charles River Laboratories?
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 Summary
The Biomanufacturing Associate II plays an integral role within CRL’s gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles, processes, procedures, inputs, and outputs, for designated production processes and handovers within a regulated environment to ensure the timely production and release of quality products, based on client specifications.
This role will apply solid knowledge and experience across a range of tasks, in resourceful and effective ways, requiring good judgment and initiative, when effectively executing manufacturing protocols.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements.
- Effectively execute a range of tasks, in line with SOPs, in one of the following areas:
o Downstream Activities (e.g., cell lysis, chromatography purification, centrifugation, Tangential Flow Filtration (TFF), and final formulation steps).
o Fill-Finish Activities (e.g., buffers and solutions filling, capping, labeling, gathering, and preparation of equipment and materials for final drug product).
- Follow instructions when performing planned manufacturing activities, in alignment with the batch record.
- Prepare, edit, and complete quality documents. Well-versed in applying GDP.
- Ensure data integrity - accurately document and review work prior to submission.
- Document, record, investigate, and report observed process variances/deviations, in real time.
- Follow instructions when operating equipment. Prepare, clean, and maintain equipment/tools.
- Troubleshoot routine issues, using root cause analysis.
- Propose and implement approved improvements.
- Create and implement safety practices, assist others, and report all incidents immediately.
- Adhere to safe working practices and comply with site-based guidelines by applying:
o Proper Personal Protective Equipment (PPE) and gowning requirements.
o Proper preparation, disinfection, sterilization, and sanitation methods/processes for equipment, etc.
o The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials.
o An understanding of biosafety levels and applying specific controls.
o Universal precautions with respect to OSHA guidelines.
o Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations.
- May assist others.
- Ensure 100% on time completion of training plan.
- Be punctual and flexible with work schedule, tasks, etc. to support business demands.
- Perform other responsibilities as required.
Job Qualifications
HS Diploma/equivalent with high grades in science and 3 years of related experience, A.S. with 2.5 years or a B.S. in biology/life sciences, bioengineering, or related discipline with 1.5 years of experience. 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. Willing to become a qualified LEAN trainer.
- Able to work in accordance with the Charles River Values.
- Foster collaboration - is a team player, with a positive attitude, professional tone, and demeanor.
- Is accountable and delivers high quality work on time.
- Willing to continuously learn and improve.
- Strong attention to detail, can recognize deviations, and has solid GDP skills.
- Solid analytical, critical thinking, problem-solving and communication skills.
- Solid knowledge/application of Word, Excel, Teams, databases, etc. Willing to learn PowerPoint.
- Pass/maintain aseptic/gowning qualifications & media fill activities; work in a cleanroom at least 4 hours/day.
The pay range for this position is $29.00 - $31.00 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.
Salary : $29 - $31
