Reporting to the Vice President, Technical Operations, oversee the manufacture and scale up of ARIKACE.
Provide Person in the Plant support for the manufacture of Insmed products.
Ensure Insmed processes, procedures and standards are followed at assigned manufacturing facilities and participate in audits designed to verify compliance.
Review batch documentation, including batch records, IQ/OQ/PQ protocols and reports, for accuracy and assure compliance with appropriate protocols and regulations prior to QA review.
Work with contract manufacture to resolve deviations, investigations, and corrective actions as necessary.
Assist in technology transfer and validation activities including but not limited to process, cleaning, and sterility assurance.
Assist in the preparation of technical reports Assist with the shipment of products from manufacturing facility to depot as required.
BS degree in a scientific discipline and a minimum 10 years of experience with sterile products or equivalent.
Extensive experience with sterile products including aseptic processing.
In-depth knowledge of cGMPs.
Experience in the scale-up and validation of complex pharmaceutical processes.
Strong communication, planning, negotiation and interpersonal skills.
Skilled in coordinating activities, evaluating data, and establishing priorities.
Productive, results-oriented, able to take proactive approaches to ensure success.
Up to 40% travel required.