Biomanufacturing Technician
Biomanufacturing Technician
Posted on :
23-07-2025
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1 Vacancy
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Job Description
Initial shift schedule (core hours) is 8:00 am - 4:30 pm w/ 30 min unpaid lunch Monday through Friday
OT and weekend work may become required
there is a possibility of extension or conversion at end of 6 months
Ideal start date is 07JUL if possible. If not due to background check 21JUL is next available start date. Yes all should begin same day.
The Biomanufacturing Associate I plays an integral role within CRLs 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 in order to proficiently execute manufacturing protocols in a regulated environment.
Key Responsibilities and Duties:
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 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).
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 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 by applying:
Cleanroom and aseptic behaviors and procedures.
Proper Personal Protective Equipment (PPE) and gowning requirements.
Proper preparation disinfection sterilization and sanitation methods and processes for equipment etc.
The safe handling transport storage and disposal of biological specimen 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.
Be punctual and flexible with work schedule tasks etc. to support business demands.
Perform other responsibilities as required.
OT and weekend work may become required
there is a possibility of extension or conversion at end of 6 months
Ideal start date is 07JUL if possible. If not due to background check 21JUL is next available start date. Yes all should begin same day.
The Biomanufacturing Associate I plays an integral role within CRLs 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 in order to proficiently execute manufacturing protocols in a regulated environment.
Key Responsibilities and Duties:
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 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).
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 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 by applying:
Cleanroom and aseptic behaviors and procedures.
Proper Personal Protective Equipment (PPE) and gowning requirements.
Proper preparation disinfection sterilization and sanitation methods and processes for equipment etc.
The safe handling transport storage and disposal of biological specimen 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.
Be punctual and flexible with work schedule tasks etc. to support business demands.
Perform other responsibilities as required.
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.
Able to work in accordance with the Charles River Values.
Able to be a team player have a positive attitude professional tone and demeanor and work effectively in a collaborative environment completing work accurately and on time.
Willing to continuously learn and improve.
Strong attention to detail able to recognize deviations and possess good GDP skills.
Good analytical critical thinking and problem-solving skills.
Good listening clear written and verbal communication skills.
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
Able to work in accordance with the Charles River Values.
Able to be a team player have a positive attitude professional tone and demeanor and work effectively in a collaborative environment completing work accurately and on time.
Willing to continuously learn and improve.
Strong attention to detail able to recognize deviations and possess good GDP skills.
Good analytical critical thinking and problem-solving skills.
Good listening clear written and verbal communication skills.
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
Employment Type
Full-time
Key Skills
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