Position Description:
Responsible for transitioning products from Development to Manufacturing as a member of the Assay Transfer team.
Job Responsibilities include, but are not limited to:
Executes research and development activities for products, methods and/or processes to ensure manufacturability.
• Prepares manufacturing documents, technical reports, summaries and quantitative analyses.
• Manufactures GMP lots and participates in process characterizations for reagents transferring to Manufacturing.
• Collaborates with other functions regarding Design Transfer activities.
• Maintains complete and accurate records.
• Presents and discusses data within and outside group
• Executes research and development activities for products, methods and/or processes to ensure manufacturability.
• Trains others in areas of expertise
• Monitors work to ensure quality, and continuously promote Quality First Time
• Uses Scaled Agile Framework to prioritize and complete work as a member of an Assay Transfer Agile team.
Skill requirements:
- Must have 5+ years of post-grad experience working in a scientific lab in the industry
- Must have 5+ years working in a manufacturing/GMP environment
- Experience with Quality Control, formulations is not required, but would be a plus
Education:
-BS Degree in a related field
Physical requirements:
**The physical demands described are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.**
- Required to stand, walk, sit, kneel, bend, crouch for a combined 4 or more hours per day.
- Required to push, pull, and lift a minimum of 50 pounds. Repetitive, consistent movements of the wrists, hands, and/or fingers. The worker is required to have good near visual acuity to perform activities throughout the processes in the assigned area.
- Must be able to wear and work in personnel protective equipment, for example: lab coat, shoe covers, ear protection, safety glasses, face shield
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