Career Opportunity: GMP Senior Project Manager at WRAIR Pilot Bioproduction Facility

The Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) is seeking a qualified GMP Senior Project Manager. This role is a critical addition to a cGMP-compliant pharmaceutical manufacturing facility that focuses on next-generation development for government agencies and cutting-edge companies.

Role Overview and Responsibilities

Based in Silver Spring, Maryland, this position is a multidisciplinary role centered on Commissioning, Qualification, and Validation (CQV). The successful candidate will use Good Engineering Practices (GEP) and a background in GMP manufacturing to lead various technical and operational initiatives.

Key responsibilities include:

• Project Coordination: Planning and reporting on project scopes related to revenue-generating technology transfer and the expansion of PBF capabilities.
• Lifecycle Management: Overseeing projects from initial planning through execution, including the management of budgets, schedules, and risks.
• Compliance and Testing: Developing protocols, managing documentation, and ensuring regulatory compliance for both processes and equipment.
• Team Leadership: Managing professional teams to ensure the delivery of high-quality pharmaceutical manufacturing standards.

About the Facility and Organization

The Pilot Bioproduction Facility (PBF) is described as a one-of-a-kind facility. Because the finish products vary, the role offers diverse opportunities for professional growth through various original projects each year.

The position is managed through CAMRIS International, LLC, a medical research and development firm that provides research management services and cost-effective programs to solve health and development challenges.

Compensation and Requirements

According to CAMRIS, the base pay range for this position is $110,000.00 to $130,000.00 per year. Actual pay is determined based on the candidate’s specific skills and experience.

Key Takeaways

• Location: Silver Spring, Maryland.
• Focus: CQV, GEP, and GMP compliance.
• Employer: CAMRIS International, LLC supporting WRAIR.
• Pay Range: $110k – $130k annually.

Frequently Asked Questions

What is the primary focus of the PBF?

The PBF is a cGMP-compliant pharmaceutical manufacturing facility that engages in next-generation development for government agencies and private companies.

What specific expertise is required for this role?

The role requires a background in GMP manufacturing and expertise in Commissioning, Qualification, and Validation (CQV), as well as the application of Good Engineering Practices (GEP).

Who is the hiring entity?

The position is offered by CAMRIS International, LLC, to support the facility at the Walter Reed Army Institute of Research.