Manufacturing Associate IV / V, Purification (Nights)
About The Position
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; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). This role’s primary focus is Downstream (Purification), involving Column Chromatography, Viral Filtration, Ultra-Filtration, and Bulk Dispensing of the drug substance.
Requirements
- Previous experience in a cGMP environment
- Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
- Experience working in an aseptic or cleanroom environment
- Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
- Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience (for IV) OR 4 years of direct experience (for V)
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 years of direct experience (for IV) OR 4.5 years of direct experience (for V)
- A High School Diploma (or equivalent) and at minimum of 3 years of direct experience (for IV) OR 5 years of direct experience (for V)
- Previous pipetting experience in a laboratory or manufacturing environment
Nice To Haves
- Previous pipetting experience in a laboratory or manufacturing environment preferred
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, 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
Mid Level
