Hobson Prior are currently working with a late-stage biotech organisation specialising in improving health all over the world through discovering, developing and commercializing pioneering vaccines to prevent serious diseases. Our client is seeking a MSAT Engineer to join them on a permanent basis based in Maryland.
- You will partner with Contract Development and Manufacturing Organizations to oversee drug substance development and manufacturing activities.
- Deliver input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages.
- Oversee execution of the validation of DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
- Preparing, reviewing, or approving process flow diagrams, development reports, and master batch records.
- Assisting with the writing and reviewing documents for INDs / regulatory section submissions.
- Prepare, review, or edit validation, CMC regulatory, and Quality documents.
- Work with other CMC team members to build and execute the CMC development plan.
- Trending of drug substance process data, identification and investigation of adverse trends.
- Partnering with CDMO representatives to investigate process and analytical deviations.
- Working closely with project managers at both the organisations and CDMO's to ensure project milestones are maintained.
- Strong project management skills.
- Ability to work collaboratively with cross functional teams.
- Excellent interpersonal and communication skills.
- MS or BS in engineering, chemistry, biology, or related discipline, plus at least 2 years of experience in vaccine or biologic manufacturing operations.
- Proven experience in collaborating in matrix teams in a technical environment.
- Knowledge of protein production and purification manufacturing technologies, such as: Cell culture, Shake flasks and stirred tank bioreactors, Clarification by depth and tangential flow filtration and Column chromatography.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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