Process Development & Validation Scientist at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

05 Oct, 26

Salary

0.0

Posted On

07 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Process Validation, GMP Regulations, Technical Writing, Experimental Design, Data Analysis, Root Cause Analysis, Technology Transfer, Process Characterization, Problem Solving, Project Management, Microsoft Office, Cross-functional Collaboration, Scientific Troubleshooting, Regulatory Compliance, Scale-up

Industry

Biotechnology Research

Description

The Process Development & Validation Scientist is responsible for designing, executing, and interpreting scientific studies that support process development, manufacturing operations, and continuous improvement initiatives within a regulated environment. This role applies scientific expertise to process optimization, process validation, troubleshooting, and data analysis while collaborating with cross-functional teams to ensure robust manufacturing processes, product quality, and regulatory compliance. The Process Development & Validation Scientist supports technology transfer, process characterization, validation activities, and commercial manufacturing by developing innovative scientific solutions and driving process improvements. Key Responsibilities Design, execute, monitor, and interpret scientific studies that support process development and manufacturing operations. Develop experimental strategies that generate robust, reliable, and reproducible data. Evaluate scientific results and provide technical recommendations based on data analysis. Support process characterization, optimization, scale-up, and technology transfer activities. Develop and implement new methodologies, protocols, and scientific approaches to improve manufacturing processes. Stay current with scientific literature, industry trends, and emerging technologies relevant to process development. Provide scientific support for commercial drug product manufacturing operations. Support process validation activities, including protocol development, execution, data analysis, and final reporting. Collaborate with Manufacturing, Quality, Engineering, Validation, and Process Development teams to resolve technical issues. Monitor process performance through data analysis and identify opportunities for continuous improvement. Provide technical support during manufacturing campaigns and process implementation activities. Support deviations, investigations, root cause analyses, and product impact assessments. Ensure scientific studies and validation activities comply with GMP requirements and applicable regulatory guidelines. Prepare scientific reports, technical protocols, validation documentation, and regulatory support documents. Participate in inspection readiness activities and provide technical support during regulatory audits. Analyze scientific and manufacturing data to identify trends and improve process performance. Interpret experimental results and communicate findings to project teams and leadership. Author technical protocols, validation documents, scientific reports, presentations, and summary documents. Maintain accurate, complete, and compliant scientific documentation. Participate in multidisciplinary teams supporting process development, manufacturing, technology transfer, and validation initiatives. Collaborate with internal stakeholders to achieve project objectives and meet project timelines. Provide technical guidance and mentorship to junior team members as appropriate. Support departmental initiatives related to safety, continuous improvement, and operational excellence. Skills Strong understanding of process development principles and experimental design. Advanced laboratory, analytical, and scientific troubleshooting skills. Knowledge of GMP regulations and regulated manufacturing environments. Strong technical writing and documentation skills. Excellent analytical, critical thinking, and problem-solving abilities. Effective verbal and written communication skills. Strong organizational and project management skills. Ability to manage multiple priorities in a fast-paced environment. Proficiency with Microsoft Office applications (Word, Excel, and PowerPoint). Ability to collaborate effectively with cross-functional teams and adapt to changing priorities. Qualifications Doctorate degree, OR Master's degree with 2+ years of scientific experience, OR Bachelor's degree with 4+ years of scientific experience. Preferred Qualifications Experience supporting drug product manufacturing in a regulated environment. Experience with process validation, including protocol development, execution, and report generation. Experience authoring technical protocols, validation documents, and scientific reports. Knowledge of process characterization, technology transfer, and manufacturing support. Strong understanding of GMP regulations and pharmaceutical manufacturing processes. Bilingual proficiency in English and Spanish is preferred. 6-month contract with possible extension Administrative Shift

Responsibilities

The scientist is responsible for designing and executing scientific studies to support process development, validation, and manufacturing operations in a regulated environment. They will collaborate with cross-functional teams to optimize processes, ensure product quality, and maintain regulatory compliance.