Process Development Scientist: Formulation & Aseptic Filling

amgen; Juncos (PR); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Total Rewards Plan

Competitive Benefits

Flexible work model

Career development

Job summary

Amgen seeks a Process Development Scientist – Commercial Support to join our team in Puerto Rico. You will help monitor and improve parenteral manufacturing processes, contribute to tech transfers, and support investigations and regulatory documentation.

The role requires advanced degrees with strong data analysis, cGMP knowledge, and bilingual English/Spanish communication. You will collaborate across Manufacturing, Quality, Engineering and Process Development, including 24/7 operations support.

Qualifications

• Doctorate or Master’s with 2+ years experience in scientific, process development or manufacturing support.
• Biopharmaceutical manufacturing experience preferred, especially formulation and aseptic filling.
• Strong communication, project management and cross-functional collaboration skills.
• Knowledge of regulated manufacturing, cGMPs, quality systems and regulatory expectations.
• Bilingual English/Spanish written and verbal communication.

Responsibilities

• Support process monitoring, improvement initiatives and technology transfers for formulation and aseptic drug product manufacturing.
• Assist deviations investigations, root cause analysis, product impact assessments and CAPA implementation.
• Author and contribute to technical documents, protocols, reports and regulatory documentation.
• Maintain awareness of literature and tech developments; communicate findings to project teams.
• Collaborate with Manufacturing, Quality, Engineering and Process Development to support commercial manufacturing.
• Perform data analysis; provide technical conclusions and recommendations to internal teams.
• Ensure work complies with safety, quality, regulatory and cGMP expectations.
• Support safety programs, continuous improvement, training and knowledge-sharing activities.

Skills

Data analysis

Statistical analysis

Cross-functional collaboration

Technical writing

Regulatory documentation

cGMP awareness

Problem solving

English/Spanish bilingual

Education

Doctorate degree

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Tools

JMP software

Job description

Amgen seeks a Process Development Scientist – Commercial Support to join our team in Puerto Rico. You will help monitor and improve parenteral manufacturing processes, contribute to tech transfers, and support investigations and regulatory documentation.

The role requires advanced degrees with strong data analysis, cGMP knowledge, and bilingual English/Spanish communication. You will collaborate across Manufacturing, Quality, Engineering and Process Development, including 24/7 operations support.