| Job Description | Responsibilities: 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
Qualifications:
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
Other:
Up to 40% travel required |
| | Company | | Insmed Inc. | Job Code | | State or Province | | New Jersey | | |
|
