Process Development Senior Scientist

QRC; Juncos (PR); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

QRC Group, LLC is seeking a Senior Process Development Scientist to support sterile drug product manufacturing within pharma/biotech. The role emphasizes aseptic processing, process characterization, validation, technology transfer, data analysis, and cross-functional leadership to ensure manufacturing readiness and continuous improvement.

The candidate will demonstrate strong scientific writing, project management, and collaboration with Manufacturing, Quality, and Regulatory teams to deliver

Qualifikationen

• Advanced degree with relevant postdoctoral experience or work history.
• Experience supporting sterile drug product manufacturing in pharma/biotech.
• Hands-on experience with aseptic filling, PPQ, tech transfer, and process support.
• Proven ability to author/execute validation protocols and reports.
• Strong GMP knowledge and contamination control understandings.

Aufgaben

• Provide scientific/technical leadership for manufacturing readiness and continuous process improvement.
• Work cross-functionally with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Develop and validate manufacturing processes and transfer to production.
• Analyze manufacturing data, identify trends, and recommend solutions.

Kenntnisse

Aseptic processing

Process characterization

Process validation

Technology transfer

Data analysis

Statistical software (JMP/Minitab)

GMP knowledge

Cross-functional collaboration

Scientific writing

Project management

Ausbildung

PhD in relevant field

MS with 3+ years experience

BS with 5+ years experience

Tools

LIMS

HLEE

JMP

Minitab

Jobbeschreibung

Company Description

is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

We are seeking a

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

We are seeking a Senior Process Development Scientist to support sterile drug product manufacturing operations within the pharmaceutical or biotechnology industry. The ideal candidate will have strong expertise in aseptic processing, process characterization, process validation, technology transfer, data analysis, and commercial process support. This role requires the ability to work cross-functionally while providing scientific and technical leadership to support manufacturing readiness and continuous process improvement.

Qualifications

• A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred. 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.
• Experience with statistical software (JMP or Minitab) and Sample Management System such as LIMS and HLEE.
• 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 strategy, 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 in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable
• Fully Bilingual (English and Spanish)

Additional Information

All your information will be kept confidential according to EEO guidelines.