Apply to Senior Biologics Manufacturing and Quality Consultant

Weil Group Inc. is identifying specialists for potential assignments within a proposed pharmaceutical manufacturing quality-system assessment. This opportunity is subject to confirmed specialist scope, project award and client confirmation.

Evaluate biologics-specific manufacturing, critical-material genealogy and Quality evidence when biological processes form part of the confirmed assessment.

What you will do

• Trace critical biological materials, intermediates and relevant process records to batches.
• Assess the evidence supporting relevant process controls and disposition decisions.
• Integrate biologics-specific findings and practical recommendations with the core team.

Mandatory requirements

• Hands-on biologics manufacturing or operational Quality experience relevant to the assigned process.
• Experience tracing critical process materials and biological manufacturing genealogy.
• Ability to relate relevant process and quality-control evidence to disposition decisions.
• Professional English for technical records, deliverables and stakeholder discussions.
• Availability for assigned on-site work in Manatí, Puerto Rico, with approved remote work where appropriate.
• Ability to meet confidentiality, site and information-handling requirements and disclose potential conflicts affecting independent assessment.

Necessary qualifications

• Typically 7 or more years of directly relevant professional experience, or a demonstrably equivalent track record.
• Understand critical controls and quality attributes of the applicable biologics process.
• Interpret relevant process records, deviations, investigations and material or intermediate linkages.
• Relevant biotechnology, biological science, pharmacy or engineering education, or equivalent practical experience.

Desired qualifications

• Experience with the production platform and specific critical materials confirmed for the project.
• Complex biological genealogy, cell-bank or seed-train tracing where applicable.
• Biologics assessment or remediation projects with implemented outcomes.

How to apply

Apply through this posting with your CV, relevant project examples, current location, availability for work in Manatí and proposed hourly or daily consulting rate. Assignment scope, duration and terms will be confirmed with selected consultants.



**Weil Group is proud to be an Equal Employment Opportunity Employer.**