# Process Development & Validation Scientist

**Company:** [BioPharma Consulting JAD Group](http://jobs.workable.com/companies/pScfjBzGATtPx3geL93jwD.md)
**Location:** Juncos, Puerto Rico
**Workplace:** on site
**Employment type:** Contract

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## 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.

## Requirements

**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.

## Benefits

-   6-month contract with possible extension
-   Administrative Shift