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Delivery Lead - Recruitment at Integrated Resources, Inc ( IRI )
Title: Biomanufacturing/ Research Associate I
Duration: 6+ months
NOTE: Training will be provided.
Job Description:
- The Biomanufacturing Associate I participate in 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, to 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, to proficiently execute manufacturing protocols in a regulated environment.
- Under guidance, apply and adhere to SOPs, cGMP, GLP, Quality, and basic Safety requirements.
- Perform a range of routine and semi-routine tasks, in accordance with SOPs, under guidance.
- 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).
- Basic Downstream Activities (e.g., assist with cell lysis, chromatography purification, centrifugation, Tangential Flow Filtration (TFF), and final formulation steps).
- Basic Fill-Finish Activities (e.g., assist with buffers and solutions for filling, capping, labeling, gathering, and preparation of equipment and materials for final drug product).
- Follow verbal and written instructions when performing planned manufacturing activities, in alignment with the batch record.
- With guidance, use basic quality documents and apply Good Documentation Practices.
- Accurately document, review, and check work to avoid errors prior to submission.
- Identify, record, and report observed process variances/deviations in real time.
- Follow SOPs, safety guidelines, and manufacturing instructions when operating equipment and completing process tasks. Prepare, clean, and maintain equipment and tools.
- Recognize common safety issues and report all incidents immediately.
- Adhere to safe working practices and comply with site-based guidelines.
- Cleanroom and aseptic behaviors and procedures.
- Proper Personal Protective Equipment (PPE) and gowning requirements.
- Proper preparation, disinfection, sterilization, sanitation methods and processes for equipment, etc.
- The safe handling, transport, storage, and disposal of biological specimens, chemical, and hazardous materials.
- Universal precautions with respect to OSHA guidelines.
- Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations.
- Ensure 100% on time completion of training plan.
Qualifications:
- HS Diploma or equivalent with high grades in science courses and 2 years of related experience, or an A.S. with 1 year, or a B.S. in biology/life sciences, bioengineering, or related discipline with 0-1 years of related experience, which may include prior experience in a technical role and/or within a cGMP and/or biotech manufacturing environment or other related industry, etc.
- Knowledge of MS Word, Excel, Teams, databases, etc.
- Pass/maintain aseptic/gowning qualifications & media fill activities; work in a cleanroom for at least 4 hours/day.
Seniority level
Employment type
Job function
Job function
Science, Research, and OtherIndustries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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