The Fountain Group is currently seeking a Bioprocess Specialist for a prominent client of ours. This position is located in Princeton, NJ.

Details for the position are as follows :

Job Description :

ONSITE : Monday-Friday 8am-5pm

The MS&T Specialist provides technical support to Princeton, NJ Facility. Manufacturing processes in a GMP environment.

Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process.

The MS&T Specialist works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions.

Other responsibilities include participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site.

The MS&T Specialist works to identify and drive continuous improvements to the manufacturing process.

Responsibilities :

Functions as a technology and process subject matter expert.

Provides on-the-floor and on-site technical support to manufacturing when necessary.

Author, review and approve, as needed, various documents (eg. Batch records, SOPs).

Author, and approve protocol and reports in accordance with internal and external regulatory expectations (Client, Engineering, Tech Transfer).

Owner of change controls for process and procedure changes.

Lead and executes CAPA system investigations.

Leads technology transfer efforts for new processes and product implementation.

Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs.

Applies continuous improvement tools to identify and close procedural and compliance gaps

Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.

Represent MSAT and interface with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.

Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirement specifications, and participating on impact assessments.

Ability to perform gowning activities and enter the manufacturing plant.

Some travel will be required.

Qualifications : Required :

Required :

BS, MS, or PhD (advanced degree preferred)

5 years pharma

3 years cell therapy biologic manufacturing process / tech support

Scientific understanding in bioprocessing principles

Experience in Process qualification, validation

Experience working with external parties and / or cross-functional teams

Experience interfacing with clients

Preferred :

Familiarity with cGMP

Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities

Experience with program management software and tools

Compensation : Up to $60 per hour depending on experience

Last updated : 2024-09-04