Dry Dosage Mfg Scientist - External & Tech Transfer

BioPharma Consulting JAD Group; Puerto Rico; Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

BioPharma Consulting JAD Group seeks a TS/MS Scientist to oversee spray dry and solid dosage manufacturing for external partners. You will ensure compliant, validated processes and write deviations and change controls.

Strong communication across teams and Spanish-English fluency are essential for collaboration with CMOs and cross-functional partners. Responsibilities include technical transfer support, CAPA investigations, data-driven process validation, and 24/7 issue resolution across time

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, or Engineering.
• 5+ years hands-on experience with spray dry, solid dosage manufacturing and packaging.
• Working knowledge of regulatory expectations (cGMPs and global guidance).
• Strong understanding of regulatory requirements in manufacturing.
• Data management across manufacturing/packaging operations.
• Proven ability to communicate and influence across teams.
• Project management experience coordinating multifaceted projects.
• Adaptable and collaborative with a positive attitude toward change.
• Fluent in English and Spanish.

Responsabilités

• Provide technical oversight for spray dry, solid dosage manufacturing and packaging processes.
• Resolve technical issues related to control strategy and manufacturing.
• Author deviations and change controls with clear documentation.
• Support CAPA closures and root cause investigations within timelines.
• Manage internal/external relationships with partners, site management, and cross-functional teams.
• Build relationships with development and central technical groups.
• Ensure processes are compliant, validated, and in control.
• Document process validation with data demonstrating capability.
• Support external partner manufacturing and packaging with monitoring and improvements.
• Assist in technical transfer and validation activities with external sites.

Connaissances

Spray drying

Solid dosage manufacturing

Packaging

Regulatory knowledge

Data management

Project management

Communication

Bilingual Spanish/English

Formation

Bachelor's degree in Chemistry, Pharmacy, or Engineering

Outils

SAP

TrackWise

Description du poste

BioPharma Consulting JAD Group seeks a TS/MS Scientist to oversee spray dry and solid dosage manufacturing for external partners. You will ensure compliant, validated processes and write deviations and change controls.

Strong communication across teams and Spanish-English fluency are essential for collaboration with CMOs and cross-functional partners. Responsibilities include technical transfer support, CAPA investigations, data-driven process validation, and 24/7 issue resolution across time