ProQuality Network
Associate Process Development Scientist 3464111
ProQuality Network, Juncos, Juncos, us, 00777
Associate Process Development Scientist 3464111
Location: East Region, Puerto Rico (Open to Puerto Republican residents who are U.S. citizens)
Work Arrangement: 100% Onsite | Administrative Shift
Duration: Approximately 6 months
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 a 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.
Seniority level:
Entry level
Employment type:
Full‑time
Job function:
Research, Analyst, and Information Technology
Industries:
Pharmaceutical Manufacturing
Interested candidates are encouraged to apply through the job description link with an updated resume for immediate evaluation.
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Work Arrangement: 100% Onsite | Administrative Shift
Duration: Approximately 6 months
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 a 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.
Seniority level:
Entry level
Employment type:
Full‑time
Job function:
Research, Analyst, and Information Technology
Industries:
Pharmaceutical Manufacturing
Interested candidates are encouraged to apply through the job description link with an updated resume for immediate evaluation.
#J-18808-Ljbffr