Manufacturing Associate IV / V, Purification (Days)

About This Role

Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on days (6:00 AM – 6:00 PM ET)

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
• Absorb and analyze in-process samples and sample analyses (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

Requirements

You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.

Qualifications

• Manufacturing Associate IV: $31.25 - $40.87 Pay Range
• The following combination of academic and/or relevant experience may be considered:
• Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience
• BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 years of direct experience
• A High School Diploma (or equivalent) and at minimum of 3 years of direct experience
• Manufacturing Associate V: $33.17 - $43.27 Pay Range
• The following combination of academic and/or relevant experience may be considered:
• Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 4 years of direct experience
• BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 years of direct experience
• A High School Diploma (or equivalent) and at minimum of 5 years of direct experience
• Previous experience in a cGMP environment
• Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
• Experience or understanding of working in an aseptic or cleanroom environment
• Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
• Previous pipetting experience in a laboratory or manufacturing environment preferred
• Problem solving, troubleshooting, and EBR experience preferred
• CMMS and TrackWise experience preferred

Skills

You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.

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
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Stock Purchase Plan
• Employee Resource Groups participation