Senior Process Development Scientist – Aseptic & Validation

Pinnaql, Inc.; Juncos (PR); Presencial; USD 120 000 - 170 000; Tempo integral

Resumo da oferta

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Process Development Sr Scientist to independently conceive and advance scientific experiments in a fast-paced setting. You will lead data-driven studies, author complexity studies, and drive process improvements across cross-functional teams.

The role emphasizes GMP compliance, aseptic processing, and robust data interpretation, with opportunities to mentor staff and influence technology transfers and validations.

Qualificações

• Experience supporting sterile drug product manufacturing in pharma/biotech.
• Hands-on aseptic filling, process characterization, PPQ, tech transfer.
• Authoring and executing validation protocols, studies, reports, investigations, changes.
• Strong GMP knowledge, aseptic processing, contamination control, quality systems.
• Ability to analyze manufacturing data and define scientifically sound solutions.
• Experience with cross-functional teams (Manufacturing, Quality, Engineering, Regulatory, Technical Services).
• Excellent technical writing, communication, and project management skills.

Responsabilidades

• Independently monitors or conducts experiments to advance projects/technologies.
• Provides advanced data analysis and interpretation, assesses impact, and makes recommendations.
• Expands knowledge beyond core area of expertise and identifies external knowledge.
• Prepares new protocols/experimental designs and leads collaborations.
• Leads department-wide support efforts including safety, recruiting, and committees.
• Develops supervisory and mentoring skills and guides junior staff.
• Plans procedures with timelines, milestones, and resources.
• Supports commercial readiness and continuous process improvement.

Conhecimentos

Sterile manufacturing

Aseptic filling

Process validation

Tech transfer

Change controls

GMP knowledge

Statistical analysis

Formação académica

Doctorate (PhD, PharmD, or MD)

Master's degree + 3+ years

Bachelor's degree + 5+ years

Engineering/Bioprocess related degree preferred

Ferramentas

JMP

Minitab

Descrição da oferta de emprego

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Process Development Sr Scientist to independently conceive and advance scientific experiments in a fast-paced setting. You will lead data-driven studies, author complexity studies, and drive process improvements across cross-functional teams.

The role emphasizes GMP compliance, aseptic processing, and robust data interpretation, with opportunities to mentor staff and influence technology transfers and validations.