Senior Dry-EM Scientist: Spray Dry, Tech Transfer & Validation

Pinnaql, Inc.; Puerto Rico; Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Pinnaql, Inc. through its Validation & Engineering Group is seeking an experienced TS/MS Scientist - Dry EM to provide technical leadership in spray dry dispersion and solid dosage manufacturing.

You will support tech transfer, process validation, deviation investigations, and CAPA closures with regulatory rigor. The role requires strong collaboration with external manufacturing partners, cross-functional teams, and the ability to operate in a 24/7 environment across time zones.

Formación

• Bachelor's degree in Chemistry, Pharmacy, or Engineering.
• 5+ years hands-on experience with spray drying and solid dosage manufacturing.
• Strong regulatory knowledge (cGMP) and global guidance.
• Excellent technical writing and CAPA/root cause experience.
• Experience with external manufacturing and CMOs.
• Bilingual English/Spanish.

Responsabilidades

• Provide technical oversight for spray dry and solid dosage manufacturing and packaging.
• Lead investigations and CAPA closures with data-driven rationale.
• Coordinate technology transfer with external partners and CMOs.
• Support validation campaigns and process qualifications.
• Maintain compliance with cGMPs and regulatory expectations.

Conocimientos

Spray Dry

Solid Dosage

cGMP Knowledge

Regulatory Experience

Data Management

Project Management

SAP

Statistical Analysis

Bilingual English/Spanish

Educación

Bachelor's degree in Chemistry/Pharmacy/Engineering

Herramientas

SAP

Process Validation Software

Descripción del empleo

Pinnaql, Inc. through its Validation & Engineering Group is seeking an experienced TS/MS Scientist - Dry EM to provide technical leadership in spray dry dispersion and solid dosage manufacturing.

You will support tech transfer, process validation, deviation investigations, and CAPA closures with regulatory rigor. The role requires strong collaboration with external manufacturing partners, cross-functional teams, and the ability to operate in a 24/7 environment across time zones.