Location: North Area, Puerto Rico
Industry: Pharmaceutical Manufacturing
POSITION SUMMARYLegal PM Partners is seeking an experienced
Principal Scientist to lead technology transfer, process optimization, and daily technical support for liquid and lyophilized parenteral manufacturing operations.
This professional will serve as a process subject matter expert, coordinating cross-functional activities to support timely product introductions and maintain robust, validated manufacturing processes aligned with regulatory filings and commitments.
The role requires strong expertise in parenteral formulation and filling, technical project leadership, and process control strategies. The selected candidate will work closely with Manufacturing, Engineering, Maintenance, IT, and other stakeholders to support technology transfers, validation activities, and manufacturing improvements.
MAIN RESPONSIBILITIES- 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.
GENERAL REQUIREMENTS- Subject matter expertise in industrial parenteral formulation and filling processes.
- Strong practical knowledge of pharmaceutical manufacturing technologies and process equipment.
- Solid understanding of cGMP, FDA requirements, and regulatory trends relevant to pharmaceutical manufacturing.
- Strong project management skills and the ability to coordinate multiple technical priorities and resources.
- Strong analytical and strategic thinking skills, with an aptitude for engineering principles.
- Ability to lead cross-functional teams, mentor scientific staff, and work independently in a complex and changing environment.
- Outstanding verbal and written communication skills in English and Spanish.
EDUCATION & EXPERIENCE- Bachelor's degree in Pharmacy, Engineering, Chemistry, or Science.
- Seven (7) years of directly related Technical Services experience within the pharmaceutical industry.
- Three (3) years of parenteral manufacturing experience with protein therapeutics/biologics strongly preferred, including knowledge of product behavior during processing.
