# Process Development Sr Scientist

> BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-08-03

**Workplace:** on_site

## Description

The Process Development Sr Scientist independently conceives, designs, implements, and advances scientific experiments that drive process understanding, technology development, and manufacturing support. This role serves as a key scientific and technical resource, contributing to project leadership, data-driven decision-making, and continuous improvement of sterile drug product operations. The scientist applies deep technical expertise, introduces innovative methodologies, and collaborates cross-functionally to ensure robust, compliant, and efficient processes.

**FUNCTIONS & RESPONSIBILITIES**

-   Independently design, execute, monitor, and interpret complex experiments or series of studies to advance process development and manufacturing technologies.
-   Prepare novel protocols and experimental designs that address technical challenges and enhance process robustness.
-   Introduce new scientific concepts, advanced technologies, and innovative approaches to strengthen process understanding.
-   Expand knowledge beyond core expertise and proactively identify relevant external scientific or competitive advancements.
-   Perform advanced data analysis using statistical tools (e.g., JMP, Minitab) to identify trends, characterize processes, and support data-driven decision-making.
-   Assess the impact of experimental results on project objectives and recommend scientifically sound actions.
-   Author high-quality scientific documentation, including technical reports, characterization studies, validation protocols, investigations, and change controls.
-   Contribute as lead author to scientific journal articles or complex technical documents when applicable.
-   Provide hands-on support to sterile drug product manufacturing, including formulation, aseptic filling, and commercial process readiness.
-   Support process characterization, technology transfer, PPQ/validation activities, and continuous improvement initiatives.
-   Analyze manufacturing data to identify process trends, deviations, and opportunities for optimization.
-   Apply contamination control principles, aseptic processing knowledge, and GMP requirements to ensure compliant operations.
-   Serve as a key contributor or project leader within independent research or technical teams.
-   Initiate productive collaborations with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
-   Mentor junior staff and develop supervisory capabilities.
-   Lead department-wide initiatives such as safety programs, recruiting efforts, and technical committees.
-   Make proactive decisions that support milestone achievement and project success.
-   Plan detailed procedures for assigned projects, including timelines, milestones, methodologies, expected outcomes, and resource needs.
-   Manage multiple projects simultaneously in a fast-paced environment while maintaining high scientific rigor and documentation quality.

**COMPETENCIES & SKILLS**

-   Strong foundation in sterile drug product manufacturing, aseptic processing, and contamination control strategy.
-   Ability to solve complex problems using scientific theory and critical thinking.
-   Demonstrated capability to independently develop scientific analyses, hypotheses, and solutions.
-   Strong laboratory skills and experience with process characterization and validation.
-   Proficiency with Microsoft Office (Excel, Word, PowerPoint).
-   Experience with statistical software such as JMP or Minitab.
-   Familiarity with sample management systems (LIMS, HLEE).
-   Ability to interpret large datasets and communicate findings clearly.
-   Ability to motivate, lead, and supervise others.
-   Strong project management skills and ability to develop realistic timelines.
-   Excellent technical writing, communication, and presentation skills.
-   Fully bilingual in English and Spanish.

## Requirements

**EDUCATION REQUIREMENTS**

-   Doctorate (PhD, PharmD, MD) with relevant postdoctoral experience where applicable **OR**
-   Master’s degree + 3 years of scientific experience **OR**
-   Bachelor’s degree + 5 years of scientific experience

**Highly Preferred Disciplines:** Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or related scientific fields.

**PREFERRED QUALIFICATIONS**

-   Experience supporting sterile drug product manufacturing in pharmaceutical or biotechnology environments.
-   Hands-on experience with aseptic filling equipment, single-use technologies, and commercial manufacturing operations.
-   Strong background in process validation (PPQ), technology transfer, and characterization studies.
-   Demonstrated ability to author and execute validation protocols, technical reports, investigations, and change controls.
-   Proven success analyzing manufacturing data, identifying trends, and recommending scientifically sound improvements.
-   Experience working in cross-functional teams and supporting fast-paced, 24/7 operations.
-   Ability to manage multiple complex projects while maintaining high quality and compliance standards.

## 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/8996EF3150/apply)

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