Principal Scientist - Parenteral Process & Tech Transfer

Legalpmpartners; Barceloneta (PR); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Legal PM Partners in North Area, Puerto Rico, seeks an experienced Principal Scientist to lead technology transfer, process optimization, and daily technical support for liquid and lyophilized parenteral manufacturing operations.

This role requires strong expertise in parenteral formulation and filling, project leadership, and process control strategies, with collaboration across Manufacturing, Engineering, Maintenance, IT, and other stakeholders.

Formación

• Subject matter expertise in industrial parenteral formulation and filling.
• Strong knowledge of pharmaceutical manufacturing technologies and process equipment.
• Solid understanding of cGMP, FDA requirements, and regulatory trends.
• Strong project management skills coordinating multiple priorities and resources.
• Ability to lead cross-functional teams and mentor scientific staff.
• Outstanding verbal and written communication skills in English and Spanish.

Responsabilidades

• Provide SME in liquid, lyophilized, and syringe parenteral manufacturing processes, including formulation and filling.
• Develop and execute technology transfer plans, project schedules, and team charters for new product introductions.
• Coordinate cross-functional resources for process support, transfers, and validation activities across portfolios.
• Collaborate with Manufacturing, Engineering, Maintenance, and IT to ensure equipment capabilities support transferred processes.
• Apply DoE, FMEA, and equipment characterization to establish effective process control strategies.
• Lead technical transfer teams and liaise for transfer, validation, optimization, and manufacturing support.
• Prepare CMC sections of regulatory submissions and coordinate inputs.
• Review validation and experimental protocols ensuring alignment with cGMP and regulatory commitments.
• Provide technical leadership and mentorship to junior scientists.

Conocimientos

Parenteral formulation and filling

Project management

Cross-functional leadership

English & Spanish communication

Educación

Bachelor's degree in Pharmacy, Engineering, Chemistry, or Science

Descripción del empleo

Legal PM Partners in North Area, Puerto Rico, seeks an experienced Principal Scientist to lead technology transfer, process optimization, and daily technical support for liquid and lyophilized parenteral manufacturing operations.

This role requires strong expertise in parenteral formulation and filling, project leadership, and process control strategies, with collaboration across Manufacturing, Engineering, Maintenance, IT, and other stakeholders.