Director, Microbiology
Costa Mesa, CA (Onsite)
Full-Time | Permanent
$190,000–$200,000
We are partnering with a confidential, commercially established sterile pharmaceutical manufacturer with a strong presence in the injectable drug product space. The organization operates a modern cGMP facility supporting commercial production and complex sterile manufacturing programs, with a clear focus on quality, regulatory excellence, and operational rigor.
As part of continued growth and strategic investment in site quality systems, they are seeking a Director of Microbiology
to lead contamination control strategy, sterility assurance, and microbiology operations across the site. This is a high-visibility leadership role with directly impact on regulatory readiness, manufacturing performance, and long-term quality culture.
Key Responsibilities
- Own and lead the Contamination Control Strategy (CCS), including lifecycle management and continuous improvement
- Oversee sterility assurance programs, including aseptic process simulations, sterility testing, endotoxin, and bioburden testing
- Direct environmental monitoring (EM) and disinfectant efficacy programs, including data trending and risk-based analysis
- Provide SME leadership for aseptic processing, sterility investigations, deviation management, and CAPA implementation
- Support manufacturing through technical guidance, change control input, and cross-functional collaboration
- Develop and lead aseptic training and operator qualification programs
- Oversee day-to-day microbiology laboratory operations, ensuring compliance with cGMP and global regulatory standards
- Manage contract testing laboratories and support regulatory inspections and audit readiness initiatives
Qualifications
- 8+ years of experience within commercial pharmaceutical or biotechnology manufacturing, including leadership experience
- Deep expertise in sterility assurance, aseptic processing, environmental monitoring, and microbiological method validation
- Strong knowledge of global cGMP regulations including FDA, ICH, EU GMP, and Annex 1
- Familiarity with USP 71>, USP 1211>, and regulatory guidance related to sterile drug product manufacturing
- Proven experience leading contamination investigations and supporting regulatory inspections
- Bachelor’s degree or higher in Microbiology, Life Sciences, Chemistry, or related discipline
This is an onsite leadership opportunity offering strong executive visibility, strategic ownership of microbiology programs, and the ability to influence contamination control culture within a growing sterile manufacturing organization. Please apply with an up-to-date resume to be considered.
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