BMA II Upstream

Rockville, MD – 06-month initial contract with possibility of extension or conversion. Core hours are 8:00 am – 4:30 pm Monday through Friday; overtime and weekend work may be required.

About the role

The Biomanufacturing Associate II plays an integral role within gene-therapy manufacturing by applying biological, bioprocess, manufacturing, mechanical, and technology principles to ensure the timely production and release of quality products in a regulated environment. This position requires solid knowledge and experience across a range of upstream tasks, executed with good judgment and initiative.

Responsibilities

• Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements.
• Execute upstream activities: solutions, media aliquot, buffer preparation, autoclave materials for cell culture, staging of raw materials, seed train, bioreactor setup, fermentation monitoring, and/or harvest.
• Follow instructions in batch records to perform planned manufacturing activities.
• Prepare, edit, and complete quality documents while maintaining Good Documentation Practices (GDP).
• Ensure data integrity by accurately documenting and reviewing work prior to submission.
• Document, record, investigate, and report process variances/deviations in real time.
• Operate, prepare, clean, and maintain equipment/tools; troubleshoot routine issues using root-cause analysis.
• Propose and implement approved process improvements.
• Create and implement safety practices; assist others and report all incidents immediately.
• Adhere to cleanroom and aseptic behaviors, proper PPE/gowning, disinfection, sterilization, and sanitation methods.
• Safely handle, transport, store, and dispose of biological specimens, chemicals, and hazardous materials.
• Apply biosafety-level controls and OSHA universal precautions.
• Maintain an organized, sanitized, and stocked work area to avoid unsafe situations.
• Complete training plan on time and remain punctual and flexible to support business demands.
• Perform other responsibilities as required.

Qualifications

• HS Diploma or equivalent with high grades in science and 3 years of related experience, OR Associate’s degree with 2.5 years of experience, OR Bachelor’s degree in biology/life sciences, bioengineering, or related field with 1.5 years of experience.
• Prior cell/gene therapy experience in a technical role within a cGMP and/or biotech manufacturing environment.
• Willingness to become a qualified LEAN trainer.
• Ability to work in accordance with client’s River Values: collaboration, accountability, continuous learning, and improvement.
• Strong attention to detail, ability to recognize deviations, and solid GDP skills.
• Analytical, critical thinking, problem-solving, and communication skills.
• Proficient in Word, Excel, Teams, and databases; willingness to learn PowerPoint.
• Ability to pass/maintain aseptic/gowning qualifications and media-fill activities; work in a cleanroom at least 4 hours/day.