Manufacturing Scientist

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

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