Associate Process Development Scientist 3464111

Title: Associate Process Development Scientist (3464111)

Location: East Region, Puerto Rico (Open to Puerto Rico residents who are U.S. citizens)

Work Arrangement: 100% Onsite | Administrative Shift

Duration: Approximately 6 months

Summary:

Our client, a leading organization within the regulated biopharmaceutical industry, is seeking a highly motivated Associate Process Development Scientist for a contract opportunity. The selected candidate will contribute to laboratory activities supporting developmental studies, process characterization, and equipment setup for commercial operations. This role requires strong technical skills, innovative problem-solving abilities, and experience working under cGMP conditions.

Key Responsibilities:

• Perform experiments, organize data, and analyze results with minimal supervision.
• Plan, conduct, and monitor laboratory studies while ensuring compliance with protocols and applicable regulations.
• Design, execute, and interpret experiments, providing technical recommendations to project teams.
• Develop and implement new or improved laboratory protocols and defect creation methods.
• Prepare syringes and vials with cosmetic, particle, or solution defects for developmental studies, training, and equipment characterization.
• Introduce new or improved laboratory methodologies for defect creation on glass and polymer surfaces.
• Conduct data analysis and integrate findings within project scope.
• Author technical documents, reports, presentations, and regulatory documentation with precision and clarity.
• Serve as a resource in areas of expertise, providing guidance and support to cross-functional teams.
• Participate in safety, quality, and departmental improvement initiatives.

Preferred Qualifications and Skills:

• Bachelor’s degree in Engineering or related scientific field.
• Creative and manual skills to develop cosmetic defects in vials and syringes using innovative, out-of-the-box approaches.
• Strong background in laboratory instrumentation: micrometers, calipers, microscopes, analytical balances, pipettes, and other lab tools.
• Knowledge of aseptic techniques, 5S, and Lean Manufacturing concepts.
• Hands-on experience in Visual Manual Inspection (VMI) techniques.
• Proficiency in Microsoft Excel, Smartsheet, and GMP-compliant electronic documentation systems.
• Familiarity with root cause analysis and problem-solving tools (5 Whys, Fishbone Diagrams).
• Strong understanding of cGMPs and compliance requirements.
• Excellent organizational skills and the ability to manage multiple priorities in a fast-paced environment.
• Effective communication and teamwork skills, with the ability to collaborate across departments.
• Service-oriented, proactive, and self-motivated professional attitude.
• Fully bilingual (English/Spanish).

Minimum Education and Experience Requirements:

• Doctorate degree, or
• Master’s degree with 2 years of directly related experience, or
• Bachelor’s degree with 4 years of directly related experience.

Core Competencies:

• Advanced scientific analysis and troubleshooting abilities.
• Strong laboratory and experimental design skills.
• Excellent written and verbal communication, including technical writing.
• Skilled in project management, analytical problem-solving, and conflict resolution.
• Demonstrated flexibility and adaptability to change.
• Proficient in computer-based data management and scientific documentation.
• Creative thinker with a strong application of scientific theory and practical techniques.

Interested candidates are encouraged to apply through the job description link with an updated resume for immediate evaluation.