Manufacturing Associate II
About The Position
Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts ( Days 6a to 6p) on a 2-2-3 calendar rotation About This Role Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; Downstream (Purification), MAs perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). U Downstream / Purification: Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance 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 environment, always focusing on audit readiness of process areas Be a team player and leader; always showing up to contribute your energy and focus Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members Who You Are You are someone with a deep passion for doing work that furthers a mission to save lives. Biomanufacturing is complex, so you have a high degree of demonstrated learning agility and love a fast-paced work environment where everything you do is incredibly impactful.
Requirements
- Bachelor’s Degree (STEM preferred) OR BioWork Certificate or Associate’s Degree transferrable experience OR High School Diploma (or equivalent) plus at least 6 months of direct and/or military experience
Responsibilities
- 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 environment, always focusing on audit readiness of process areas
- Be a team player and leader; always showing up to contribute your energy and focus
- Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
