Process Development Scientist ProQN941

ProQualityNetwork; Juncos (PR); Híbrido; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

ProQualityNetwork in Puerto Rico seeks a Process Development Scientist to design, execute, and evaluate experiments that advance manufacturing processes. You will generate reliable data and contribute to process development objectives in a fast-paced, 24/7 environment.

The role requires strong scientific writing, proficiency in English and Spanish, and collaboration across functions to drive improvements and regulatory readiness. Hybrid onsite preference in Juncos, PR.

Formación

• MS or BS with relevant scientific experience in process development.
• Experience in commercial biopharmaceutical manufacturing, preferably formulation and aseptic filling.
• Knowledge of protein science, formulation, and filling processes.
• Experience with process monitoring, data trending, and statistical tools such as JMP.
• Experience with deviations, investigations, and root cause analysis.
• Ability to provide manufacturing floor support in a fast-paced 24/7 environment.
• Bilingual fluency in Spanish and English.
• Strong technical writing for regulatory audits.

Responsabilidades

• Conceive, design, execute, and evaluate scientific experiments and strategies.
• Develop and assess experimental approaches for new processes and reliable data.
• Ensure studies follow approved protocols and regulatory requirements.
• Analyze data and interpret results to assess impact on objectives.
• Stay current with scientific developments and industry literature.
• Provide technical guidance on experimental design and troubleshooting.
• Prepare scientific reports, technical summaries, and regulatory documentation.
• Support department initiatives, including safety programs and recruiting.
• Establish and manage project timelines to deliverables.

Conocimientos

Biopharmaceutical manufacturing

Process development

Data analysis

Regulatory understanding

Cross-functional collaboration

Bilingual Spanish/English

Educación

MS in Science/Engineering

BS in Science/Engineering

Herramientas

JMP

Descripción del empleo

Title: Process Development Scientist - ProQN941

Location: Juncos, PR (Open to Puerto Rico residents only)

Work Arrangement: Hybrid (onsite preferred)

Shift: Administrative shift, with availability to support 24/7 operations based on business needs

Positions: 1

Contract Duration: 1 year

Position Summary

Our client is seeking a Process Development Scientist to design, execute, and evaluate scientific experiments that support process development activities and project objectives. Under general supervision, this professional will contribute scientific expertise, generate reliable experimental data, and support the development and optimization of manufacturing processes.

Preferred Qualifications

• Background in Science or Engineering.
• Relevant experience in commercial biopharmaceutical manufacturing, preferably supporting formulation and aseptic filling operations.
• Understanding of protein science, formulation, and filling processes.
• Experience with process monitoring, data trending, and statistical analysis tools such as JMP.
• Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
• Ability to provide manufacturing floor support in a fast-paced, 24/7 operating environment.
• Bilingual proficiency in Spanish and English, both written and verbal.
• Strong technical writing skills, including preparation of documentation for regulatory audits.
• Excellent communication, presentation, problem-solving, project management, and cross-functional collaboration skills.

Key Responsibilities

• Conceive, design, execute, and evaluate scientific experiments and experimental strategies.
• Develop and assess experimental approaches that support new processes and generate robust, reliable data.
• Ensure studies are conducted in accordance with approved protocols, applicable guidelines, and regulatory requirements.
• Analyze and interpret experimental data, evaluate results, and assess their impact on project objectives.
• Stay current with scientific developments, industry literature, emerging technologies, and relevant areas of expertise.
• Identify and communicate relevant scientific and technological developments.
• Introduce advanced scientific methods and develop innovative protocols to address specific technical challenges.
• Represent the department on project teams under the guidance of senior scientific staff.
• Establish productive collaborations within and outside the department.
• Provide technical guidance and support to colleagues in experimental design, data interpretation, troubleshooting, and implementation of solutions.
• Independently prepare scientific reports, technical summaries, complex regulatory documentation, invention disclosures, and patent submissions, as applicable.
• Participate in external scientific and professional activities.
• Support department-wide initiatives, including safety programs, recruiting activities, and committees, as needed.
• Develop supervisory and mentoring capabilities.
• Establish and manage project timelines to ensure timely completion of assigned deliverables.

Education Requirements

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

• Master's degree with at least 2 years of scientific experience; or
• Bachelor's degree with at least 4 years of scientific experience.

Required Competencies and Skills

• Advanced scientific analysis, troubleshooting, and laboratory skills.
• Strong understanding of scientific principles and their practical application.
• Ability to design and conduct scientific experiments, interpret results, and develop innovative solutions.
• Strong knowledge of current Good Manufacturing Practices (cGMP).
• Excellent verbal and written communication skills, including technical writing.
• Strong analytical thinking, problem-solving, negotiation, and conflict-resolution skills.
• Project management, organizational, and multitasking abilities.
• Ability to motivate, guide, and supervise others, as needed.
• Effective cross-functional collaboration and interpersonal skills.
• Flexibility and ability to adapt to changing priorities and business needs.
• Computer proficiency in a Windows environment, including Microsoft Word, Excel, and PowerPoint.
• Full bilingual proficiency in English and Spanish.