Manufacturing Associate II

Manufacturing Associate 2

Position Overview:

Unique opportunity to help start up and operationalize 2 new recently acquired facilities in Gaithersburg, Maryland. We are looking for highly motivated and versatile individuals to fill a challenging yet rewarding role as we look to commission and validate the facilities to produce our novel vaccines. This role requires a diverse skill set to assist with a variety of technical, operational, and project responsibilities. Must be highly flexible and collaborative to drive cross-functional success at the site and coordinate with tech transfer teams.

Intake Call notes:

• Candidates will be working in both up and downstream manufacturing, experience in downstream is more preferable at the moment

• • Selling point for position is candidates will be able to learn both up and downstream components of biomanufacturing
• Scheduled has rotating Saturdays, on call work and does require some days to go over 8 hours, people at MA2 level should be familiar with this

• Candidates who want to be part of a team will thrive here, flexibility is a must

Responsibilities include but are not limited to:

• Cell amplification of suspension-based insect cells through shaker flasks, bioreactors, and disposable bioreactors.
• Infection and harvest processes using continuous centrifugation and depth filtration.
• Purification steps using flow-through and column capture chromatography.
• Drug substance formulation.
• In-house buffer preparation and support activities.

Production Performance:

• Accountable for daily adherence to production schedule.
• Diagnose and respond to unusual conditions with proper communication to management.
• Perform tasks with a safety-first mentality and awareness of surrounding environment.
• Work under cGMP conditions with general guidance for tasks with prior experience.
• Work with trained colleagues for operations with no prior experience.

Technical Operations:

• Assist with operations only as properly instructed by experienced team members.
• Proactively pursuing training needs per assigned curriculum.
• Serve as SME/Trainer on at least one unit operation.
• Author SOP’s and Batch Records.
• Perform introductory technical writing assignments.

Compliance:

• Assist in maintaining work area in state of inspection readiness.
• Adhere to cGMP and GDP guidelines.
• Operate only in accordance with an approved process or document.
• Report any instance of a procedure or document being insufficient for processing to department management.
• Assist with complex comments in GMP documentation while informing department management.

Minimum Requirements:

• Bachelor's degree (engineering or biological science is preferred) with 1+ year of industry experience, Associate degree with 2+ years of industry experience, or No degree with 3+ years of industry experience.
• Exhibit solid understanding of scientific principles as they relate to manufacturing processes.
• Demonstrate interpersonal, technical aptitude, and problem-solving skills.
• Knowledge in principles and practice of current Good Manufacturing Practices (cGMPs) from development or commercial applications.
• Effectively contribute to a team environment with safety at the forefront.
• Flexible availability including weekends and holidays.
• Experience with multi-tasking and organizational skills.
• Show proficiency in verbal, written, and interpersonal communication skills.
• Ability to troubleshoot, identify root causes, and systematically resolve problems.
• Proficient in Window based software to include Excel and Word. Ability to adapt to changing software programs.

Recommended Skills

• Adaptability
• Biology
• Coordinating
• Good Manufacturing Practices
• Infectious Diseases
• Interpersonal Communications