Biomanufacturing Technician
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Apply Now Application ends in 27d 3h 28min
Job Detail
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Offered Salary 0
Job Description
Job Description
The Biomanufacturing Associate I is a vital part of the gene therapy manufacturing team, utilizing biological, bioprocess, manufacturing, and mechanical principles in a cGMP and GLP environment to ensure the production and release of high-quality products according to client specifications. This role involves performing various routine and semi-routine tasks, requiring judgment to resolve issues or make recommendations, with guidance when necessary, in order to effectively execute manufacturing protocols within a regulated setting.
Responsibilities
- Apply and adhere to SOPs, cGMP, GLP, Quality, and basic Safety requirements under guidance.
- Perform routine and semi-routine tasks according to SOPs in areas such as upstream activities, downstream activities, and fill-finish activities.
- Follow verbal and written instructions in alignment with the batch record during planned manufacturing activities.
- Utilize basic quality documents and apply Good Documentation Practices with guidance.
- Document, review, and check work accurately to prevent errors prior to submission.
- Identify, record, and report observed process variances/deviations in real time.
- Operate equipment and complete process tasks by following SOPs, safety guidelines, and manufacturing instructions.
- Prepare, clean, and maintain equipment and tools.
- Recognize common safety issues and report incidents immediately.
- Adhere to safe working practices and comply with site-based guidelines, including cleanroom and aseptic procedures, PPE and gowning requirements, and safe handling of biological specimens and hazardous materials.
- Ensure 100% on-time completion of the training plan.
- Be punctual and flexible with work schedule to support business demands.
- Perform other responsibilities as required.
Essential Skills
- Experience with cGMP, GLP, and SOPs.
- Knowledge of aliquoting, cell culture, chromatography, Tangential Flow Filtration (TFF), fill finish, and GDP.
- Strong attention to detail and ability to recognize deviations.
- Good analytical, critical thinking, and problem-solving skills.
- Proficiency in MS Word, Excel, Teams, and databases.
Additional Skills & Qualifications
- High School Diploma or equivalent with high grades in science courses and 2 years of related experience, or an A.S. with 1 year, or a degree in biology/life sciences, bioengineering, or related discipline with 0-1 years of related experience.
- Ability to work in accordance with established values and as a team player.
- Positive attitude, professional tone, and effective collaboration skills.
- Willingness to continuously learn and improve.
- Pass/maintain aseptic/gowning qualifications & media fill activities.
- Ability to work in a cleanroom for at least 4 hours/day.
Apply Now
Application ends in 27d 3h 28min