SUMMARY
With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

QUALIFICATIONS

• Experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
• Proficient and experienced in owning Change Controls.
• Project Management and/or Quality Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
• Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English, with ability to collaborate productively with technical and senior management staff.
• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.

EDUCATION/EXPERIENCE
-Bachelors + 4 years of Manufacturing Operations experience