GMP Manufacturing Oversight Consultant– Advanced Therapy Products
This is a temporary 6-month contracted 1099 position with no benefits.
On-site at third-party GMP manufacturing facilities. One full-time consultant per site (MD & MA).
About the Role:
Medvacon Life Sciences is seeking two senior-level consultants to serve as on-site oversight representatives at external GMP manufacturing facilities. These individuals will provide structured oversight across the entire manufacturing process for a gene therapy product, including pre-batch readiness, production execution, and fill-finish operations.
This is a non-interventionist role focused on real-time observation, verification of procedural adherence, and structured communication with internal quality and technical operations stakeholders. Consultants will be present on site during all production days, operating under strict access protocols and formal communication channels. Success in this role requires deep technical expertise in aseptic manufacturing for gene therapy or other advanced therapy products, as well as the ability to engage professionally and constructively in complex production environments.
Key Responsibilities:
• Maintain a full-time on-site presence to observe GMP manufacturing operations from material staging through final fill-finish
• Monitor compliance with approved procedures, aseptic techniques, equipment setup, gowning practices, line clearance, and room readiness
• Observe the handling of materials and components used in small-batch, high-value drug product manufacturing
• Confirm operational readiness prior to production start, when permitted
• Use approved mechanisms for process observation, including live video feeds, adjacent viewing areas, and suite access where authorized
• Record daily observations in a structured and objective format for internal review
• Review process data and executed records at the conclusion of each production day following site-level release
• Communicate observations and feedback solely through assigned site points of contact, in accordance with structured protocols
• Participate in required safety, gowning, and operational training, and complete all qualification activities prior to floor access
• Represent oversight interests with professionalism, discretion, and focus on process alignment and manufacturing continuity
Required Qualifications:
• Minimum of 10 years of experience in GMP manufacturing for biologics or advanced therapy products
• Strong technical background in aseptic processing, fill-finish operations, and upstream preparation activities
• Deep understanding of gene therapy manufacturing requirements, including environmental control, sterility assurance, and contamination risk management
• Proven ability to support oversight in structured access environments without participating in production
• Familiarity with small-scale, high-value product workflows involving complex material handling and documentation
• Experience working with or alongside contract manufacturing organizations under controlled communication and access frameworks
• Strong documentation and observation skills with the ability to recognize and escalate compliance or process risks appropriately
• Excellent communication and interpersonal skills; capable of representing oversight interests constructively in dynamic environments
• Ability to pass cleanroom gowning qualification and complete all required training modules prior to operational access
• Full-time availability to work on site and support oversight across multiple consecutive production days
Work Conditions:
• Full-time, on-site presence required at designated manufacturing locations during all active production windows
• Viewing access and observation approach may vary based on process and facility protocol
• Consultants will operate from a designated workspace when not observing operations
• Role is strictly limited to structured oversight and documentation, with no direct participation or process control responsibilities
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.