Bio/Sterile Drug Product Process Expert (Hybrid/Remote)

Real Staffing; Boston (MA); Hybrid; USD 140,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Health savings account

Retirement plan

Life insurance

Disability insurance

Paid time off

Job summary

Real Staffing is seeking a Bio/Sterile Drug Product Process Expert to oversee sterile manufacturing at CMOs, ensuring compliant processes and timely investigations. This 12-month contract role emphasizes technical leadership, cross-functional collaboration, and regulatory readiness.

The ideal candidate has a strong background in sterile formulations, aseptic fill/finish, and GMP/GxP with experience in regulatory filings and continuous improvement initiatives in a global environment.

Qualifications

• BS or MS in a relevant technical field with experience in sterile drug product formulation and process development.
• GxP and multinational regulatory guidelines knowledge is required.
• Experience with regulatory submissions and external CMOs is preferred.

Responsibilities

• Provide day-to-day technical oversight of activities at external CMO partners.
• Drive investigations, changes and continuous improvements in line with team goals.
• Collaborate with Quality, Operations, Supply Chain and Manufacturing.
• Review manufacturing processes and CPV for commercial products.
• Participate in Joint Technical Team coordination with CMOs and SMEs.
• Perform risk assessments and contribute to regulatory filings.

Skills

Sterile formulation

Aseptic fill/finish

GxP knowledge

Regulatory submissions

Process risk assessment

Regulatory inspections

Statistical analysis (Minitab/JMP)

Cross-functional collaboration

Problem-solving tools

Education

BS in Pharmaceutical Sciences or Chemical Engineering

Tools

Minitab

JMP

Job description

Real Staffing is seeking a Bio/Sterile Drug Product Process Expert to oversee sterile manufacturing at CMOs, ensuring compliant processes and timely investigations. This 12-month contract role emphasizes technical leadership, cross-functional collaboration, and regulatory readiness.

The ideal candidate has a strong background in sterile formulations, aseptic fill/finish, and GMP/GxP with experience in regulatory filings and continuous improvement initiatives in a global environment.