About the position
This requisition represents multiple open positions in our manufacturing organization. The Talent Acquisition team continually assesses all applicants that apply through this posting and will reach out to prospective candidates to discuss current and future opportunities. Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. 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; with two main areas/disciplines – Upstream (Cell Culture) and Downstream (Purification). MAs perform these critical steps within Current Good Manufacturing Practice (cGMP) biosafety cabinets and cleanroom suites.
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
Requirements
- Bachelor’s Degree (STEM preferred) OR BioWork Certificate or Associate’s Degree OR Military training & experience and are soon to transition OR High School Diploma (or equivalent) plus at least 6 months of related experience
- Foundation in targeted biopharmaceutical training is preferred, but not required
- Strong desire to learn and grow quickly - demonstrated experience employing learning agility
- Adaptable to changing needs and demands, comfortable navigating a dynamic environment
- 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)
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
