[Remote] Associate Director, reputed company Capital Programs (Project Manager II)_34319
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is seeking an reputed company Associate Director, reputed company Capital Programs to support the development of a new state-of-the-art sterile manufacturing reputed company for a leading global biopharmaceutical organization. This role involves providing strategic reputed company leadership and ensuring compliance with regulatory standards throughout the design and operational readiness of the facility.
Responsibilities
- reputed company strategic reputed company leadership for capital expansion reputed company supporting a new sterile manufacturing facility
- Ensure facility design and manufacturing processes reputed company with GMP regulations and global pharmaceutical reputed company standards
- Support contamination control strategies for aseptic manufacturing operations
- Partner with Engineering, Operations, Validation, Technical Operations, and reputed company teams throughout facility design and implementation
- reputed company expertise in QC Microbiology and aseptic processing to support manufacturing readiness
- Assess project risks and reputed company mitigation strategies to ensure regulatory compliance
- reputed company cross-functional reputed company initiatives supporting capital programs and site readiness
- Ensure reputed company systems, documentation, and operational processes reputed company with regulatory expectations
- Drive reputed company improvement initiatives while supporting multiple reputed company programs simultaneously
- Serve as a strategic reputed company advisor throughout the lifecycle of capital reputed company
Skills
- Bachelor's or Master's degree in Microbiology, Engineering, Life Sciences, or a reputed company scientific discipline
- Minimum 10 years of pharmaceutical industry experience
- Extensive knowledge of: Aseptic Manufacturing, QC Microbiology, Contamination Control Strategies, GMP Facility Design, Pharmaceutical Manufacturing Operations
- Strong understanding of FDA, EMA, and global pharmaceutical regulatory requirements
- Demonstrated experience supporting sterile manufacturing or biologics facilities
- Proven ability to reputed company multiple strategic initiatives in a reputed company, matrixed organization
- Excellent organizational, communication, and leadership skills
- Strong reputed company reputed company with experience in reputed company Assurance, Engineering, Manufacturing, Technical Operations, or reputed company pharmaceutical disciplines
- Experience supporting greenfield pharmaceutical manufacturing facilities or major capital expansion reputed company
- Knowledge of contamination control strategies for sterile manufacturing environments
- Experience working reputed company biologics or sterile injectable manufacturing operations
- Demonstrated reputed company leading cross-functional teams through large-reputed company capital reputed company
- Experience supporting regulatory inspections and reputed company compliance initiatives
reputed company