Process Development Scientist
BioPharma Consulting JAD Group
- Juncos, PR
- Autónomo
- Tiempo completo
- Conceive, design, and execute scientific experiments under general guidance.
- Analyze and interpret experimental data to assess impact on project goals.
- Develop and implement novel protocols to address specific technical challenges.
- Ensure studies are conducted in compliance with applicable guidelines and regulations.
- Monitor scientific literature and technology trends relevant to the role.
- Lead development and execution of equipment characterization strategies.
- Design and implement testing protocols, including SATs and challenge validations.
- Author technical reports, validation documentation, and risk assessments.
- Apply QRAES methodology to support risk-based decision making.
- Support new equipment installations through validation planning and execution.
- Collaborate with internal departments to support project execution and troubleshooting.
- Represent the department on project teams and contribute to cross-functional initiatives.
- Mentor junior staff and contribute to department-wide efforts such as safety and recruiting.
- Communicate project status and findings effectively to stakeholders.
- Doctorate degree
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Strong knowledge of cGMP regulations and validation processes
- Experience with vision system technologies and inspection/packaging concepts
- Fully bilingual in English and Spanish
- Expertise in equipment and process characterization
- Experience developing testing strategies and validation protocols
- Strong technical writing and documentation skills
- Familiarity with risk assessment methodologies (e.g., QRAES)
- Ability to solve routine technical problems and manage change effectively
- Strong verbal communication, negotiation, and conflict resolution skills
- Project management experience in a regulated environment
- 5-month contract
- Administrative Shift