The Manufacturing Associate II will perform processing steps within the Upstream and Downstream processes of cGMP manufacturing activities onsite at a well respected Biomanufacturing Company located in Research Triangle Park (RTP).

This is an opportunity to be part of a team where you can learn, grow your skillset, AND have the support you need with a career coach guiding you towards success :)

Oppurtunites working the Night or Day Shift:

6-6 working a 2-2-3 shift with differential pay nights and weekends

Needed for success:

• Amazing work ethic that shines
• High adaptability and willingness to tackle whatever comes your way
• Positive and motivated attitude

Downstream / Purification:

• Buffer Preparation
• Column Chromatography
• Viral Filtration
• Ultra-Filtration
• Bulk Dispensing of the drug substance
• Purification

Upstream / Cell Culture:

• Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors
• Performing thaws and splits utilizing Aseptic technique
• Dispensing raw materials + batching of media & solutions
• Isolation
• Cell Culture
• Harvesting
• Media Preparation

What You’ll Do:

• Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Document and record all cGMP data & information (including deviations) for processing steps and equipment activities. Create and revise key documentation like batch records, SLRs, and equipment logbooks
• Assist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, Cell Counts, etc.)
• Help maintain a clean and safe work environmentBe a team player and always showing up to contribute your energy and focus

Qualifications:

• Associate’s Degree with 6 months of experience
• High School Diploma (or equivalent) plus the Biowork certification & 1 year of experience
• Strong communication skills (both verbal and written) and ability to work as a part of a team
• Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds
• Capable of working twelve (12) hour shifts (we operate both day and night shifts)