Aseptic Manufacturing Director — Biotech Scale-Up

Replimune-2; Framingham (MA); On-site; USD 188,500 - 243,500; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401k match

Flexible time off

Job summary

Replimune is building a new Framingham production facility to manufacture our oncolytic immunotherapies. The Director Manufacturing will define and oversee drug product manufacturing operations, ensuring sterile quality and adherence to CCS and international standards.

The role collaborates with Operations, Engineering, Validation, Facilities, Quality Control and Quality Assurance to support GMP document management and continuous improvement in day-to-day operations.

Qualifications

• BA in Engineering/Biology/Chemistry/Biochemistry/Microbiology or related science with minimum 10 years experience, or Master's with 8 years.
• Experience leading teams in GMP-regulated aseptic environments.
• Technical experience in sterile product development and control implementation (e.g., CCS) and visual inspection.
• Strong problem-solving skills and attention to detail.
• Experience communicating with health authorities (FDA, EMA).

Responsibilities

• Oversee aseptic operations at Framingham facility, ensure environmental monitoring and sterile product quality.
• Lead risk management for aseptic controls and cross-contamination/particulate strategy.
• Plan and manage day-to-day operations: scheduling, batch records, DP formulation and filling.
• Support investigations, CAPA closure, protocol execution, and documentation for sterile operations.
• Coordinate with Facilities, Engineering and Validation for preventative maintenance and calibration.
• Deploy new technologies for continuous improvement and future manufacturing suites.
• Develop and retain staff, ensuring readiness for product launches.
• Engage with industry to shape aseptic strategies and regulatory expectations.
• Maintain safety standards in accordance with OSHA and environmental laws.

Skills

Sterile product development

Aseptic operations leadership

Cross-functional collaboration

Regulatory communication (FDA/EMA)

Problem solving

Quality systems

Education

Bachelor's/Master's in Engineering, Biology, Chemistry, Biochemistry, Microbiology

Tools

CCS (Contamination Control Strategy)

Visual inspection

Job description

Replimune is building a new Framingham production facility to manufacture our oncolytic immunotherapies. The Director Manufacturing will define and oversee drug product manufacturing operations, ensuring sterile quality and adherence to CCS and international standards.

The role collaborates with Operations, Engineering, Validation, Facilities, Quality Control and Quality Assurance to support GMP document management and continuous improvement in day-to-day operations.