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 MS&T Senior Engineer/Manager to join them on a permanent basis based in Maryland.

Job Responsibilities:

• You will work with Contract Development and Manufacturing Organizations to oversee drug product development and manufacturing activities.
• Accountable to provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages.
• Co-operate with global project managers at both client and CDMO's to ensure project milestones are maintained.
• Trend drug product process data, identification, and investigation of adverse trends.
• Prepare, review, or approve process flow diagrams, development reports, and master batch records.
• Oversee the execution of the validation of DP processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
• Assist with the writing and reviewing documents for regulatory submissions.
• Prepare, review, or edit validation, CMC Regulatory, and Quality documents.
• Collaborate with other CMC team members to build and execute the CMC development and manufacturing plan.
• Work with CDMO representatives to investigate process and analytical deviations.

Key Skills:

• Excellent interpersonal and communication skills.
• Proven experience in collaborating in matrix teams in a technical environment.
• Strong project management skills and ability to work collaboratively with cross functional teams.

Requirements:

• MS or BS in engineering, chemistry, biology, or related discipline.
• A minimum of 3-5 years of experience in aseptic drug product manufacturing operations.
• Knowledge of aseptic drug product manufacturing requirements.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.