The posting
Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative shift (flexible hours based on business needs)
Position Overview
We are seeking an experienced Principal Scientist Lead to provide technical leadership and manufacturing process expertise within a regulated pharmaceutical and biotechnology manufacturing environment. The selected candidate will be responsible for supporting technology transfers, new product introductions, manufacturing process optimization, validation, and ongoing technical support of liquid and lyophilized parenteral products. This position will serve as a Subject Matter Expert (SME) and process owner for end-to-end manufacturing processes, ensuring successful technology transfers, robust manufacturing operations, product quality, and compliance with applicable cGMP regulations and regulatory requirements.
Required Qualifications
- Bachelor’s degree in pharmacy, Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum of seven (7) years of directly related experience in Technical Services, Manufacturing Science & Technology (MS&T), or pharmaceutical manufacturing.
- Strong technical knowledge of pharmaceutical manufacturing processes, technologies, and processing equipment.
- Demonstrated expertise in parenteral manufacturing processes, including formulation, filling, and sterile manufacturing operations.
- Experience supporting technology transfers, process validation, and manufacturing process optimization.
- Knowledge of cGMP regulations, FDA requirements, pharmaceutical manufacturing standards, and regulatory expectations.
- Experience with process characterization, Design of Experiments (DoE), risk assessments, and Failure Mode and Effects Analysis (FMEA).
- Strong understanding of engineering principles and manufacturing equipment capabilities.
- Demonstrated project management experience, including the coordination of multiple technical projects, schedules, and resources.
- Ability to lead cross-functional teams and drive technology transfer and process implementation activities.
- Strong analytical, problem-solving, strategic thinking, and decision-making capabilities.
- Excellent organizational skills and ability to manage competing priorities in a fast-paced manufacturing environment.
- Strong interpersonal, leadership, mentoring, and team development skills.
- Excellent written and verbal communication skills in both English and Spanish.
Preferred Qualifications
- Three (3) or more years of experience in parenteral manufacturing of protein therapeutics or biologics.
- Direct experience with liquid and lyophilized sterile manufacturing processes.
- Experience with prefilled syringe manufacturing and associated formulation and filling technologies.
- Advanced knowledge of biologics formulation and product behavior during parenteral manufacturing processes.
- Experience leading New Product Introduction (NPI) and technology transfer projects across multiple manufacturing sites.
- Experience supporting regulatory submissions, particularly CMC documentation and manufacturing process sections.
- Experience with process validation, process characterization, and manufacturing control strategies.
- Demonstrated ability to lead technical teams and mentor scientists and engineering professionals.
Key Responsibilities
- Serve as the Subject Matter Expert (SME) for liquid, lyophilized, and prefilled syringe parenteral manufacturing processes, including formulation and filling operations.
- Lead and support technology transfer activities for new products introduced from Research & Development (R&D), other manufacturing sites, contract manufacturers, and external business partners.
- Develop, coordinate, and execute technology transfer plans, ensuring alignment with manufacturing schedules, project milestones, and business priorities.
- Participate in and provide technical leadership to New Product Introduction (NPI) and cross-functional technology transfer teams.
- Oversee manufacturing process readiness, ensuring equipment, automation systems, facilities, and operational resources can support transferred processes.
- Collaborate with Manufacturing, Engineering, Maintenance, Quality Assurance, Information Technology, and other functional teams to ensure successful process implementation and ongoing manufacturing support.
- Lead process optimization, troubleshooting, and continuous improvement initiatives to improve manufacturing performance, productivity, process robustness, and product quality.
- Develop and execute Design of Experiments (DoE), Process Risk Assessments, Failure Mode and Effects Analysis (FMEA), and equipment characterization studies.
- Establish and recommend appropriate process control strategies to ensure manufacturing consistency, process reliability, and regulatory compliance.
- Support process validation activities, including development, review, and approval of validation and experimental protocols, as applicable.
- Ensure manufacturing processes are appropriately designed, validated, and maintained in accordance with cGMP requirements, site procedures, and approved regulatory filings.
- Provide technical guidance and recommendations for process changes, manufacturing improvements, and implementation of pharmaceutical industry best practices.
- Serve as the primary technical liaison for assigned product portfolios, coordinating technology transfer, validation, optimization, and ongoing manufacturing support activities.
- Support the preparation, review, and authorship of Chemistry, Manufacturing, and Controls (CMC) documentation and regulatory submissions related to manufacturing processes.
- Lead or represent the site in technology transfer initiatives, ensuring timely execution of project objectives and deliverables.
- Identify opportunities for process innovation, cost reduction, productivity improvement, and operational excellence.
- Provide technical leadership, mentoring, and development to junior scientists and technical personnel.
- Coordinate technical resources, project priorities, and schedules to ensure successful execution of manufacturing and technology transfer activities.
- Maintain effective communication with site leadership, corporate technical groups, and cross-functional stakeholders regarding project progress, technical challenges, and operational priorities.
Key Deliverables
The selected resource will be responsible for developing, leading, reviewing, and/or coordinating:
- Technology Transfer Plans, project schedules, and implementation strategies.
- New Product Introduction (NPI) and manufacturing readiness assessments.
- Manufacturing process characterization and optimization studies.
- Design of Experiments (DoE) and Process Risk Assessments (FMEA).
- Process control strategies and equipment characterization documentation.
- Process validation strategies, protocols, and supporting reports.
- Technical assessments and recommendations for manufacturing process changes.
- CMC documentation and regulatory submission content related to manufacturing processes.
- Manufacturing troubleshooting assessments and continuous improvement initiatives.
- Technical project plans, progress reports, and cross-functional coordination activities.
- Technical procedures, process documentation, and applicable manufacturing guidelines.
- Resource planning, technical recommendations, and knowledge transfer activities.
