Biomanufacturing Associate I - Downstream

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 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). 
•    Follow verbal and written instructions (e.g., SOPs), when performing planned manufacturing activities, in alignment with the batch record, and under guidance. 
o    Performing routine sampling (e.g., collecting and preparing) and inspections. 
o    Assisting in material transfer processes. 
•    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. 
o    Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations. 
•    Seek input from others, positively respond to feedback, make appropriate course corrections to learn from and avoid repeating the same mistakes. 
•    Attend and complete relevant training, apply to work tasks, and maintain training documentation. 
•    Responsible to ensure 100% on-time completion of new hire training plan.
•    Is 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: 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. 
•    Strong attention to detail and ability to recognize deviations from accepted practices.
•    Good documentation and GDP skills.
•    Must possess good analytical, critical thinking, and problem-solving skills. 
•    Able to hold oneself accountable by following up and doing what they say they will do. 
•    Able to complete work accurately and on time. 
•    Good listening, clear