Sr. Associate/Specialist MS&T - Tech Transfer Documentation

Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

The Sr. Associate/Specialist, MS&T supports the MS&T team by creating, updating and ensuring accuracy of presentations & various documentation (Word, Excel, proprietary database) requirements associated to tech transfer and process development for client process summary reports. Knowledge of cell culture and/or fermentation, bioreactors, column chromatography, membrane chromatography and tangential flow filtration (TFF) desirable.

Key responsibilities include but are not limited to:

• Coordinate with manufacturing to collect, analyze and report client process data
• Preparation of Bills of Materials (BOM), materials specifications and SOPs
• Assist with preparation of Tech Transfer documents such as process descriptions and scale-up documents
• Work closely with project management to ensure milestones are achieved
• Assist with performing scale up calculations based on process information from PD

Education & Experience:

• Sr. Associate: HS Degree/GED or Associates Degree in a scientific or engineering discipline with 8 years of experience in a GMP Biologics Manufacturing, Process Development or Tech Transfer role
• Specialist Bachelor degree in a scientific or engineering discipline with 0-3 years experience in a GMP Biologics Manufacturing, Process Development or Tech Transfer role
• High competent with MS Word, Excel, Power Point
• Knowledge of gene therapy, protein production, virus production, vaccine manufacture and/or fill and finish operations preferred
• Demonstrated experience building credibility within the group by performing high quality work

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.