Biomanufacturing Technician

Job Description

Job Summary:

• The Biomanufacturing Associate I plays an integral role within client’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, 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.

Duties and Responsibilities:

• 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.

Education and Experience:

• 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, Skills and Abilities:

• Able to work in accordance with the client 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.