• Set direction and provide leadership of Process Validation programs employing a risk-based approach and enabling client projects to move from clinical to commercial production
• Develop and implement process validation policies and related procedures based on current regulations and industry standards to support the company's growth and regulatory requirements.
• Collaborate with cross-functional teams, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Manufacturing, to facilitate and drive process validation for clinical and commercial programs.
• Support additional areas of Validation focus, including Cleaning Validation), Water System Performance Qualifications, and Environmental Monitoring Performance Qualification (EMPQ).

The essential requirements of the job include:

• 7+ years of pharmaceutical industry with 5+ years of cGMP experience; Biologics CDMO experience preferred
• Bachelor’s degree in chemistry, statistics, or science-based discipline with 7+ years of experience in the pharmaceutical or life sciences industry

It would be a plus if you also possess previous experience in:

• Knowledge of full validation life cycle and cGMP compliance
• Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality driven processes and end products

The salary range OR the hourly range for this role is <insert range>. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.