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Director, Sterility Assurance (Relocation Available)

National Resilience

National Resilience

west chester, oh, usa
Posted on Friday, April 19, 2024
Relocation Assistance Offered

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary:

The Director, Sterility Assurance is accountable for developing and overseeing the implementation of the contamination control program at Resilience. This is an exciting opportunity to contribute to maintain a robust and comprehensive program. The Director, Sterility Assurance will collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the Resilience network.

The Director, Sterility Assurance will also support new product transfers related to contamination control aspects of the manufacturing process including equipment design, materials of construction, performance qualifications, disinfectant efficacy, aseptic processes and techniques, and microbial method validations.

This is a site based role in West Chester, OH and reports to the Site Quality Head.

Position Responsibilities:

  • Accountable for the implementation and lifecycle management of Contamination Control program.

  • Lead the network Sterility Assurance program, including supporting manufacturing sterility investigations (example: aseptic process simulations, drug product sterility testing, and other microbial excursions).

  • Support inspection readiness plans and interact with regulatory agencies during inspections on matters related to site Contamination Control and Sterility Assurance.

  • Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and with multiple stakeholders.

  • Experience with oversight of aseptic processing and the associated international aseptic processing regulations.

Minimum Qualifications:

  • Substantial in a leadership role within the pharmaceutical or biotechnology industry

  • Strong knowledge of microbiological testing including drug product sterility, endotoxin, aseptic process simulations, and sterile manufacturing sterility investigations

  • Excellent oral and written communication skills with strong technical writing experience

Preferred Qualifications:

  • Bachelor’s degree or higher in Life Sciences, Microbiology, Chemistry, Engineering, or a related field

  • Demonstrated knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP, and JP monographs for microbiology

  • Strong familiarity with USP <1211> Sterility Assurance, USP <71> Sterility Testing, and FDA Guidance for Industry - Sterile drug products

  • Knowledge of Biosafety Level (BSL) requirements and use of risk assessment for the selection of appropriate microbiological practices

  • Comprehensive knowledge of global GMP regulatory requirements for Aseptic Controls

  • Knowledge and familiarity with Annex 1

    Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

    Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $150,000.00 - $217,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.