Parenteral Process Leader & Tech Transfer Scientist

Legal Project Management Partners; Arecibo (PR); Presencial; USD 120.000 - 180.000; Tempo integral

Resumo da vaga

Legal PM Partners in ARECIBO, PR invites a seasoned Principal Scientist to lead technology transfer, process optimization, and technical support for liquid and lyophilized parenteral manufacturing.

This professional will coordinate cross-functional activities to support timely product introductions and maintain robust, validated manufacturing processes aligned with regulatory filings and commitments.

Qualificações

• Bachelor’s degree in Pharmacy, Engineering, Chemistry, or Science.
• 7 years of directly related Technical Services experience within the pharmaceutical industry.
• 3 years of parenteral manufacturing experience with protein therapeutics/biologics strongly preferred, including knowledge of product behavior during processing.
• Experience with DoE, FMEA, and process validation.

Responsabilidades

• Provide subject matter expertise in liquid, lyophilized, and syringe parenteral manufacturing processes, including formulation and filling.
• Develop and execute technology transfer plans, project schedules, and team charters to support new product introductions.
• Coordinate cross-functional resources for process support, productivity improvements, technology transfers, and validation activities across the product portfolio.
• Collaborate with Manufacturing, Engineering, Maintenance, and IT to confirm that equipment and automation capabilities can successfully deliver transferred processes.
• Apply Design of Experiments (DoE), process risk assessments/FMEA, and equipment characterization to establish effective process control strategies.
• Lead technical transfer teams and serve as a liaison for transfer, validation, optimization, and manufacturing support activities.
• Prepare process sections of Chemistry, Manufacturing and Controls (CMC) submissions and coordinate regulatory process inputs.
• Review or approve validation and experimental protocols within assigned authority, ensuring alignment with cGMP requirements and regulatory commitments.
• Provide technical leadership and mentorship to junior scientists and support the development of team capabilities.
• Prioritize technical projects and coordinate personnel and financial resources to support project objectives.
• Identify process improvement opportunities and relevant industry best practices to strengthen manufacturing performance.

Conhecimentos

Parenteral formulation

Parenteral filling

Process excellence

Project management

Cross-functional leadership

Bilingual English/Spanish

Formação

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

Descrição da vaga

Legal PM Partners in ARECIBO, PR invites a seasoned Principal Scientist to lead technology transfer, process optimization, and technical support for liquid and lyophilized parenteral manufacturing.

This professional will coordinate cross-functional activities to support timely product introductions and maintain robust, validated manufacturing processes aligned with regulatory filings and commitments.