Sterility Assurance Lead (Associate Director)

Role Summary

As a Sterility Assurance Lead, you will play a vital role in ensuring the sterility and quality of our manufacturing processes. You will collaborate across teams to implement and maintain robust sterility assurance programs, ensuring regulatory compliance. This role offers the opportunity to make a meaningful impact on patient health while growing your expertise in a supportive and inclusive environment. Location: King of Prussia, PA (on-site).

Responsibilities

• Be the key contact for the Site for all matters related to Sterility Assurance including Aseptic Practices, Environmental monitoring plans, Surface Cleaning and Sanitization, Sterilization, Media Fill and Sterility Failures and provides expert support to production, engineering and QA.
• Coordinate the team which define, organize and maintain over time the (1) proper microbiological environmental and aseptic operator monitoring plans, (2) the proper microbiological monitoring plans for Utilities and other microbiological samples (e.g. prefiltration bioburden) and (3) execute media fills for the initial validation and re-validation.
• Coordinate, organize and execute other validation activities such as biovalidation, facility and utilities validation.
• Maintain and ensure aseptic procedures are in place and in use.
• Support investigations where aseptic assurance is at risk.
• Project support for aseptic assurance. Oversight of microbial control strategy.
• Be active member of aseptic member quality network. Manage cost center.
• Ensures the structure is appropriately sized and fosters the development of team members' skills.
• Promotes a collaborative and stimulating work environment where everyone can contribute.
• Encourages professional growth through training, regular feedback, mentoring, and coaching programs, ensuring each team member has opportunities to excel and contribute to the organization's overall success.
• Responsible for ensuring that Risk assessments, Risk communication and action planning are completed in accordance with our Risk Management System (RMS) within the relevant business area. Risks may be relevant to Business, Business continuity, Safety, People, Wellbeing, Compliance, Quality, Costs.

Qualifications

• Required: Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific field; Minimum of 5 years of experience in sterility assurance or aseptic manufacturing within the pharmaceutical, biopharma or biotech space; Experience with regulatory inspections and audits; Experience with aseptic techniques and cleanroom operations.
• Preferred: Advanced degree in Microbiology, Biology, Chemistry, or a related field; Experience in a leadership role within sterility assurance or quality assurance; Knowledge of risk assessment tools and methodologies; Familiarity with validation processes for aseptic manufacturing; Strong problem-solving and analytical skills; Strong knowledge of regulatory requirements for sterility assurance (e.g., FDA, EMA); Proven ability to lead investigations and implement corrective actions; Excellent communication and collaboration skills.

Education

• Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific field.