Biomanufacturing Associate I
6 days ago
The Biomanufacturing Associate I will play a critical role in Charles River Laboratories' gene therapy manufacturing function by applying biological, bioprocess, manufacturing, and mechanical principles to ensure the timely production and release of quality products.
Key Responsibilities- 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:
- 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).
- Performing routine sampling (e.g., collecting and preparing) and inspections.
- 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.
- 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.
- 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 written, and verbal communication skills.
- Working knowledge of computer software (MS Word, MS Excel, Teams, database systems, etc.).
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