Biomanufacturing Associate II - Downstream Job 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 will play an integral role within CRL’s gene therapy manufacturing function by applying solid knowledge and biomanufacturing experience when performing across a range of tasks, in resourceful and effective ways, requiring good judgment and initiative in order to effectively execute manufacturing protocols within a cGMP and GLP environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements
- Effectively execute a range of tasks, in accordance with SOPs, in following areas:
o Cell lysis
o IDX purification
o Viral vector purification methods
o Depth filtration
o Membrane filtration
o Tangential Flow Filtration (TFF)
o FPLC (AKTA) chromatography purification
o Final formulation steps
- Follow verbal and written instructions when performing tasks, aligned with the batch record including:
o Monitoring production ensuring proper documentation, data recording and analysis
o Performing various filter integrity tests
o Preparing buffers and solutions as well as assisting others
o Recording/reporting process variances and deviations and assisting with investigations
o Supporting and maintaining SOPs and quality systems
o Performing material transfer processes
- Use quality documents (NCRs, BPRs) and effectively apply GDP and data integrity
- Troubleshoot routine issues. Document and escalate if required
- Adhere to safe working practices and policies and apply:
o PPE and gowning requirements in a cleanroom
o Proper preparation, disinfection, sterilization, and sanitation processes
o Safe handling and disposal of biological specimen, chemical, and hazardous materials
o Understanding of biosafety levels and specific controls
- May assist interns, trainees, and BMA I
- Use Continuous Improvement/LEAN tools to identify issues, root causes, and implement solutions
- Ensure sustainable right-first-time performance
- Complete new hire training
- Be punctual and flexible with work schedule, tasks, etc. to meet customer and other critical demands
- 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
- Other:
- Able to work in accordance with the Charles River Values
- A team player with a positive attitude, who can work effectively in a collaborative environment
- Willing and able to continuously learn and improve
- Strong attention to detail and GDP skills; can recognize deviations from accepted practices
- Must possess solid analytical, critical thinking, and problem-solving skills
- Able to hold oneself accountable by following up and doing what they say they will do
- Will take pride in one’s work products – delivered on time, with high quality & limited rework
- Solid listening, clear written, and verbal communication skills
- Solid knowledge and application of computer software (MS Word, MS Excel, Teams, database systems, etc.). Will also learn basic PowerPoint skills
The pay range for this position is $60,000 - $65,000. 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.
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