Job Description
Job Description
The Process Development Scientist is responsible for conceiving, designing, executing, and interpreting scientific experiments that support the successful advancement of departmental or cross-functional projects. The role involves generating reliable data, ensuring compliance with protocols and regulatory standards, and developing innovative experimental approaches. This individual contributes to both the technical and strategic elements of scientific programs and may represent the function on cross-functional teams.
Key Responsibilities
- Develop and implement experimental strategies to address scientific questions and support development objectives
- Execute and troubleshoot laboratory studies following current protocols and good documentation practices
- Analyze data, interpret results, and assess impact to process or product development
- Prepare scientific reports, validation protocols, technical summaries, and regulatory support documents
- Collaborate across functional teams and contribute to project milestones and timelines
- Monitor relevant literature, apply new concepts, and introduce best practices in experimental design
- Participate in departmental initiatives such as safety programs, mentoring, and knowledge sharing
Requirements
Required Qualifications
- Doctorate degree, or
- Master’s degree and 5 years of relevant scientific experience, or
- Bachelor’s degree and 6 years of relevant scientific experience
Preferred Qualifications
- Advanced understanding of vision system technologies and inspection/packaging processes
- Experience with process and equipment characterization, including protocol development and execution
- Proficient in validation strategies, including support for SATs, risk assessments, and QRAES
- Strong knowledge of cGMPs and regulatory expectations in the life sciences or manufacturing setting
- Demonstrated skills in data analysis, problem-solving, and technical writing
- Fully bilingual in English and Spanish
- Effective communicator with experience in collaborative environments
- Strong organizational and project coordination skills
- Proficiency in Microsoft Word, Excel, and PowerPoint