# Process Development Scientist - Manufacturing

> BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-07-07

**Workplace:** on_site

## Description

The Process Development 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, troubleshooting, investigations, and data analysis while collaborating with cross-functional teams to ensure robust manufacturing processes, product quality, and regulatory compliance.

**Key Responsibilities**

-   Design, execute, monitor, and interpret scientific studies to support process development and manufacturing operations.
-   Develop experimental strategies that generate robust, reliable, and scientifically sound data.
-   Evaluate scientific results and provide technical recommendations based on data analysis.
-   Support process characterization, optimization, and technology transfer activities.
-   Develop and implement new methodologies, protocols, and experimental approaches to improve manufacturing processes and resolve technical challenges.
-   Stay current with scientific literature, industry trends, and emerging technologies relevant to process development.
-   Provide scientific support for commercial manufacturing operations, including formulation and aseptic filling processes.
-   Collaborate with Manufacturing, Quality, Engineering, Validation, and Process Development teams to resolve technical issues.
-   Support manufacturing floor activities by providing process expertise in a fast-paced production environment.
-   Monitor process performance through data trending and statistical analysis.
-   Identify opportunities for process optimization and continuous improvement.
-   Support deviations, investigations, root cause analyses, and product impact assessments.
-   Ensure scientific studies and process development activities comply with GMP requirements and applicable regulatory guidelines.
-   Prepare scientific reports, technical summaries, protocols, validation documentation, and regulatory support documents.
-   Participate in audit readiness activities and provide technical support during regulatory inspections.
-   Analyze manufacturing and experimental data using statistical tools to identify trends and improve process performance.
-   Interpret results and communicate findings to project teams and leadership.
-   Author technical reports, scientific documentation, protocols, and presentations.
-   Present scientific findings to cross-functional teams and management.
-   Participate on multidisciplinary teams supporting process development, technology transfer, manufacturing, and continuous improvement initiatives.
-   Collaborate with internal and external stakeholders to achieve project objectives.
-   Mentor junior scientists and provide technical guidance as appropriate.
-   Support departmental initiatives related to safety, operational excellence, and knowledge sharing.
-   Manage project timelines and ensure timely completion of assigned deliverables.

**Skills**

-   Strong understanding of process development principles and experimental design.
-   Knowledge of GMP regulations and regulated manufacturing environments.
-   Excellent analytical, laboratory, troubleshooting, and problem-solving skills.
-   Strong statistical analysis and data interpretation capabilities.
-   Excellent technical writing, documentation, and presentation skills.
-   Strong verbal and written communication skills.
-   Effective project management and organizational skills.
-   Ability to manage multiple priorities in a fast-paced environment.
-   Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
-   Strong collaboration skills and the ability to work effectively across cross-functional teams.

## 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**

-   Degree in Life Sciences, Biochemistry, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences, or a related scientific discipline.
-   Experience supporting process development or commercial biotechnology/pharmaceutical manufacturing.
-   Understanding of protein science, formulation development, and aseptic manufacturing processes.
-   Experience with process monitoring, statistical analysis, and data trending.
-   Experience using statistical software such as **JMP** or similar analytical tools.
-   Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
-   Strong technical writing skills with experience preparing scientific, validation, or regulatory documentation.
-   Bilingual proficiency in English and Spanish.

## Benefits

-   6-month contract with possible extension
-   Administrative Shift

## Apply

[Apply at BioPharma Consulting JAD Group](https://apply.workable.com/biopharma-consulting-jad-group/j/B3F79F17AE/apply)

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