GMP Manufacturing Oversight Consultantâ Advanced Therapy Products
GMP Manufacturing Oversight Consultantâ Advanced Therapy Products
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
This is a temporary 6-month contracted 1099 position withno 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 @. If you receive a message that seems suspicious or is not from our official domain please report it immediately to
Required Experience:
Manager
Employment Type
Full-Time
