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location: Norwood, Massachusetts
job type: Permanent
salary: $80,000 - 100,000 per year
work hours: 9 to 5
This is a newly created role in the Manufacturing Science and Technology (MST) department to support the company's aseptic (sterile) drug product fill and finish internal manufacturing and external Contract Manufacturing Organization activities in the USA. This role will provide direct support for aseptic drug product fill and finish technology transfer, process start up, process validation and commercial cGMP manufacturing including cross site technical issues/investigations.
Reporting to the Director, Drug Product, MS&T, the incumbent will work alongside company manufacturing operations and Quality Assurance to ensure robust, compliant cGMP drug product manufacturing performance internally and at CMOs within the USA to meet production schedules.
- Be a subject matter expert (SME) for drug product fill/finish (aseptic manufacturing) processes at the company's CMOs.
- Work with a company Drug Product team (Operations, QA, Supply Chain), to be a point of contact for technical issues that occur at CMOs.
- Provide technical support of cGMP manufacturing including supporting technology transfer documentation, change control, and manufacturing investigations. Collaborate with process development on studies to determine root cause for deviations.
- Analyze manufacturing performance through data review and analyses. Author manufacturing summary reports. Establish and maintain data repositories.
- MS&T will be providing weekend coverage for Manufacturing and as part of the team you will need to be flexible to work a weekend day on a rotational basis
- BS, M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.). BS with 5 to 8 years of experience or MS with 2 to 5 years experience in a pharmaceutical or biotechnology company.
- Experience in cGMP aseptic (sterile) fill finish operations including prior experience supporting validation of aseptic manufacturing processes.
- Knowledge of data management tools and statistical analysis.
- Excellent judgment and ability to communicate manufacturing issues in a scientifically sound and understandable way along with ability to provide data driven solutions.
- A highly collaborative team player capable working in a cross-functional matrix environment.
- Ability to manage projects in a fast-paced environment.
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
skills: GMP (Good Manufacturing Practice), Manufacturing Operations
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.