Process Developement Scientist- ProQN534

Frey Consulting Group; Juncos (PR); Hybrid; USD 95,000 - 135,000; Part time

Job summary

Frey Consulting Group seeks an experienced Senior Process Development Scientist to independently design and lead experiments advancing biopharmaceutical processes. You will interpret complex data, guide technical decisions, and drive process development within a regulated environment.

The role requires cross-functional leadership, strong writing and communication skills, and experience with sterile manufacturing, validation, and technology transfer. Hybrid onsite support is offered.

Qualifications

• Experience supporting sterile drug product manufacturing.
• Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategies, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.

Responsibilities

• Independently plan, monitor, and conduct experiments to advance projects, technologies, and processes.
• Provide advanced data analysis, interpret results, and make scientifically grounded recommendations.
• Develop new experimental designs, protocols, methodologies, and approaches.
• Lead cross-functional collaboration to support process development and manufacturing initiatives.

Skills

Sterile drug product manufacturing

Aseptic processing

Data analysis

Technical writing

Project management

Cross-functional collaboration

Bioprocess engineering knowledge

Bilingual English/Spanish

Chemical engineering knowledge

Education

Doctorate (PhD, PharmD, or MD)

Master’s degree

Bachelor’s degree

Tools

JMP

Minitab

LIMS

HLEE

Microsoft Office

Job description

Process Developement Scientist- ProQN534

Tittle: Senior Process Development Scientist ProQn534

Work Schedule: On-site | Administrative Shift (Hybrid)

Shift Requirements: Availability to work different shifts and/or weekends based on business needs

Positions Available: 2

Contract Duration: 6 months

Important Notice: This opportunity is available exclusively to direct individual candidates. Third-party contractor submissions, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Position Overview

Our Client is seeking experienced Senior Process Development Scientists to independently conceive, design, implement, and advance scientific experiments that contribute to the successful completion of projects and technical objectives.

The selected professionals will serve as senior scientific and technical resources, providing advanced data analysis, scientific interpretation, experimental design, and project leadership. This role requires the ability to work independently, develop innovative solutions, collaborate across functions, and support process development and manufacturing initiatives in a regulated pharmaceutical or biotechnology environment.

Key Responsibilities

• Independently plan, monitor, and conduct experiments, studies, or series of experiments to advance projects, technologies, and processes.
• Provide advanced data analysis and interpretation, assess the impact of experimental results, and make scientifically sound recommendations.
• Develop new and novel experimental designs, protocols, methodologies, and approaches.
• Apply scientific theory and critical thinking to solve complex technical and process-related challenges.
• Expand knowledge beyond the core area of expertise and identify relevant external scientific and competitive knowledge.
• Serve as a key contributor to research and project teams while providing technical and scientific leadership.
• Establish productive collaborations across departments and, when appropriate, with external partners.
• Introduce and evaluate new technologies, methodologies, and scientific concepts.
• Develop detailed project plans, including timelines, milestones, methodologies, expected results, and required resources.
• Make proactive scientific and technical decisions that support project milestones and business objectives.
• Prepare complex technical documents, reports, protocols, and other scientific documentation.
• May contribute to scientific publications and technical documents as a lead author.
• Support department-wide initiatives, including safety programs, recruiting activities, and committees.
• Develop supervisory, mentoring, and leadership capabilities.
• Support multiple projects in a fast-paced, regulated manufacturing environment.

Education & Experience

Candidates must meet one of the following educational and experience combinations:

• Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience, where applicable; or
• Master’s degree with 3+ years of relevant scientific experience; or
• Bachelor’s degree with 5+ years of relevant scientific experience.

A degree in one of the following disciplines is highly preferred:

• Mechanical Engineering
• Chemical Engineering
• Biomedical Engineering
• Bioprocess Engineering
• Pharmaceutical Sciences
• Biotechnology
• Biology
• Microbiology
• Related scientific discipline

Required Technical Experience

• Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
• Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategies, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
• Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Strong technical writing, communication, presentation, and project management skills.
• Ability to independently manage multiple projects while supporting commercial readiness and continuous process improvement.
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable.
• Experience with technical data analysis and scientific documentation.
• Proficiency with Microsoft Office, including Excel, Word, and PowerPoint.
• Experience with sample management systems such as LIMS and HLEE.

Core Competencies

The ideal candidate should demonstrate:

• Ability to motivate, lead, and/or supervise the activities of others.
• Strong project management and organizational skills, including the ability to develop realistic timelines.
• Strong problem-solving skills and the ability to apply scientific theory to complex challenges.
• Ability to independently determine and develop scientific analyses and solutions.
• Ability to exercise considerable latitude when establishing scientific work objectives.
• Strong laboratory and project management skills.
• Creativity in developing new hypotheses and approaches for scientific experimentation.
• Strong critical evaluation and detailed interpretation of experimental results.
• Understanding of the scientific relevance and business impact of targeted work.
• Strong communication and presentation skills.
• Ability to work effectively in a cross-functional, fast-paced environment.
• Bilingual proficiency in English and Spanish.

Ideal Candidate Profile

The successful candidate will be an experienced scientific professional who can operate independently while providing technical leadership across process development and manufacturing initiatives. The role is particularly suited for someone with hands-on experience in sterile pharmaceutical manufacturing, aseptic processing, filling operations, process validation, data analysis, and technical documentation, combined with strong project management and cross-functional collaboration skills.