Supply Chain Manager

Amniotics is seeking a Supply Chain Manager / QA who will manage Amniotics supply chain and participate in QA activities for GMP manufacturing of cells under aseptic conditions. Areas of responsibility could also include preparing and reviewing CMC related documents for clinical trial applications as well as having contact with suppliers of facility and other services.


The candidate will help improve processes for material and services supply as well as supplier handling to ensure clinical and commercial supply. The position will report to the COO.


Responsibilities
· Manage all aspects of supply chain including purchasing and shipping
· Establish and manage strategic sourcing of raw materials and production supplies, including materials of biological origin.
· Manage all purchasing, warehousing activities, receiving, shipping, storage and inventory control while adhering to cGMP regulations
· Develop KPI (Key Performance Indicators) to monitor performance
· Manage vendor oversight, relationships and selection related to supplies and raw materials
· Work closely with the engineering and production teams to clearly understand technical requirements and sensitivities as they relate to manufacturing
· Identify and mitigate areas of risk with supplier and vendors
· Work closely with R&D to source new materials for future and current projects.
· QA responsibilities as part of the QA team (e.g. QMS maintenance, quality assurance tasks related to deviations, CAPAs, change control


Qualifications
· Minimum BS degree in biological sciences, biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
· Experience in procurement of biological raw and starting materials for biopharmaceutical based GMP manufacturing operations a must.
· Experience with supplier qualification
· Experience with Quality Assurance
· Experience with CMC activities
· Experience in equipment procurement, maintenance and validation a plus.




Please note this job description is not an exhaustive listing of activities, duties or responsibilities for this job. Duties, responsibilities and activities may change over time. This is a permanent position with a 6-month trial period.