Manufacturing Associate II/III (Purification Small Scale)
- Full-time
- Region: US
- Department: Manufacturing
Job Description
About This Role
In Purification, we perform critical downstream processing activities within Current Good Manufacturing Practice (cGMP) cleanroom suites at our Research Triangle Park (RTP) facility. These processes include Buffer Preparation, Column Chromatography, Viral Filtration, Ultra Filtration and Bulk Dispensing of the drug substance. Our Manufacturing Associates must be flexible and demonstrate learning agility to perform a variety of complex tasks to produce both clinical and commercial products in a fast-paced environment. This position provides value to our organization by ensuring precise manufacturing of our life-changing therapies. This includes manufacturing therapies for multiple sclerosis, alzheimer’s disease and more. This manufacturing role supports the overall supply chain that delivers our therapies to the patients that need them. Our supply chain was recently listed by Gartner as a ‘Top 25 Supply Chain.’ This Manufacturing Associate position requires a willingness to work evenings and weekends to accommodate production schedules.
Qualifications
What You’ll Do
- Work in and help maintain a safe working environment
- Perform and monitor critical downstream processes
- Help maintain cleanliness and audit readiness of process area
- Perform and document cGMP activities according to standard operating procedures, solution lot records and batch production records
- Perform in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, etc.)
- Purification steps using flow-through and column capture chromatography
- Perform Bulk Fill/ Dispensing using Aseptic technique
- Buffer preparation and production support activities (COP, Autoclave, etc.)
- Perform column packing and qualifications
- Effectively contribute in a dynamic team environment
Who You Are
If you are a highly detailed, focused individual that enjoys problem solving and team work, you are a great fit for our manufacturing team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives.
Required Education / Experience
Manufacturing Associate II:
High school diploma (or equivalent) in addition to 6 months of direct experience/1 year of related experience OR
BioWork Certificate, Associate’s Degree, or Bachelor’s degree with limited to no experience
Manufacturing Associate III:
High school diploma (or equivalent) in addition to 1.5 years of direct experience/3 years of related experience OR
BioWork Certificate or Associate’s Degree in addition to 1 year of direct experience/2.5 years of related experience OR
Bachelor’s degree with 6 months of direct experience/2 years of related experience
Additional Information
All your information will be kept confidential according to EEO guidelines.