BMA II Upstream

HonorVet Technologies (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States.

About the role

The Biomanufacturing Associate II plays an integral role within a client's gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles, processes, procedures, inputs, and outputs for designated production processes and handovers within a regulated environment. This role ensures the timely production and release of quality products based on client specifications. The position requires solid knowledge and experience across a range of tasks, executed with good judgment and initiative while following manufacturing protocols.

Responsibilities

• Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements.
• Execute tasks in Upstream Activities, including:
  • Solutions, media aliquot, and buffer preparation.
  • Autoclaving materials for cell culture.
  • Staging of raw materials.
  • Seed train, bioreactor setup, fermentation monitoring, and/or harvest.
• Follow instructions for planned manufacturing activities in alignment with the batch record.
• Prepare, edit, and complete quality documents while applying Good Documentation Practices (GDP).
• Ensure data integrity by accurately documenting and reviewing work prior to submission.
• Document, record, investigate, and report observed process variances/deviations in real time.
• Operate equipment, prepare, clean, and maintain tools, and troubleshoot routine issues using root cause analysis.
• Propose and implement approved improvements.
• Create and implement safety practices, assist others, and report all incidents immediately.
• Adhere to safe working practices, including:
  • Cleanroom and aseptic behaviors and procedures.
  • Proper Personal Protective Equipment (PPE) and gowning requirements.
  • Preparation, disinfection, sterilization, and sanitation of equipment.
  • Safe handling, transport, storage, and disposal of biological specimens, chemicals, and hazardous materials.
  • Understanding of biosafety levels and applying specific controls.
  • Universal precautions with respect to OSHA guidelines.
  • Organization, sanitizing, and stocking of work areas to avoid unsafe situations.
• Assist others as needed.
• Ensure 100% on-time completion of training plans.
• Be punctual and flexible with work schedules and tasks to support business demands.
• Perform other responsibilities as required.

Requirements

• High School 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 a related discipline with 1.5 years of experience.
• Prior cell/gene therapy experience in a technical role within a cGMP and/or biotech manufacturing environment or related industry.
• Willingness to become a qualified LEAN trainer.
• Ability to work in accordance with core values, fostering collaboration with a positive attitude and professional demeanor.
• Accountability for delivering high-quality work on time.
• Commitment to continuous learning and improvement.
• Strong attention to detail, ability to recognize deviations, and solid GDP skills.
• Analytical, critical thinking, problem-solving, and communication skills.
• Proficiency in Word, Excel, Teams, and databases; willingness to learn PowerPoint.
• Ability to pass and maintain aseptic/gowning qualifications and media fill activities.
• Capability to work in a cleanroom for at least 4 hours per day.

Schedule

06 months (contract position).