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location: Norwood, Massachusetts
job type: Permanent
salary: $110,000 - 120,000 per year
work hours: 8 to 4
Reporting to the Senior Manager of US External Manufacturing, the Specialist/ Engineer II
will be part of a team responsible for the manufacturing activities at 3rd-party contract manufacturing organizations (CMO). RESPONSIBILITIES
- Ensure operational and technology transfer activities are performed completely and compliantly at CMOs to deliver a quality product and meet our requirements
- Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality.
- Review instructions relating to external production operations and ensure their strict implementation by the CMOs
- Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate requirements.
- Coordinate and perform the reviews for process performance and Key Performance Indicators at CMOs.
- Drive for and implement agreed continuous improvements at CMOs.
- Coordinate reviews and approvals of various documentations from CMOs.
- In collaboration with Quality, Technical Development, and MS&T, coordinate investigations and troubleshooting efforts at CMOs.
- Write or revise the appropriate GMP documentations.
- Frequently visit and maintain presence at the external partners' sites (as global travel situation allows).
- Performs other administrative duties as required.
- Bachelor's degree in Engineering or Sciences and 2-5 years or MS with 0-2 years of industry experience.
- Considerable understanding of concepts and principles related to drug substance manufacturing is preferred
- Excellent communication skills (verbal and written) to collaborate with CMC Management in a dynamic, cross-functional matrix environment.
- Well organized - a natural ability to be organized in how you think, communicate and conduct your work
- You drive for results - you set a high bar for yourself and others
- Good critical thinker that can anticipate the needed next step and therefore can work independently
- A curious mindset that allows you to constantly learn and challenge the status quo
- Ability to navigate through ambiguity and rapid growth and adapt to change.
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.