Manufacturing Associate - Upstream
Paragon Bioservices, Inc. (PBI) is a growing bio pharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI 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.
This role is responsible for supporting the overall GMP cell culture manufacturing process, through the application of experience and GMP documentation to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II GMP manufacturing.
Lifting up to 40 lbs. unassisted may be required at times. Shift work and/or weekend work may be required at times.
Key Responsibilities include but are not limited to:
- GMP cell culture processes at large scale (media/buffer prep, seed prep, culturing, harvest equipment, SIP and CIP)
- Review and/or draft internal or external documents (SOPs, BRs)
- Maintain training records and logbooks
- Monitor/ request/ perform maintenance of equipment including fermentation and harvest equipment.
- Recommending equipment, supply purchases within the production areas
- Developing creative solutions to operational problems within the scope of production parameters
- May work in Process Development to transfer production projects into GMP Production on
- Work with production management to schedule manufacturing projects
- Manage interactions with Quality for routine tasks sample submission, deviation resolution and batch record preparation
- Interacting with clients during manufacturing campaigns as needed
- Participating in facility expansion and equipment validation
- Assisting management with GMP and Safety training of manufacturing staff
- Other duties as assigned
Experience & Education:
- High School Diploma plus 5+ years of experience - OR -
- B.S. in a Life Sciences discipline and 3+ years of experience - OR -
- M.S. in a Life Sciences discipline and 2+ years of experience
- Experience Includes biologic, pharmaceutical or medical device industry performing direct hands-on work with cell culture reactors and with processes to produce bulk biologics (proteins, antibodies, etc.)
- Have the knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
- Well-versed in Good Manufacturing Practices (GMPs)
- Mature professional capable of independent 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