Director, Quality Control Microbiology

Resilience • East Norriton Township, PA

1d

About The Position

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, Quality Control - Microbiology reports to the Site Quality Head in the East Norriton, PA. site. The Director is accountable for developing, implementing and managing the microbial contamination control program and microbial testing at the manufacturing plant. This is an exciting opportunity to contribute to a cell therapy operation by, establishing a robust and comprehensive environmental monitoring program and managing the microbiology testing of materials, intermediates and drug products.

Requirements

• Experience with managing EM programs, utilities monitoring, and drug product microbiological testing.
• Experience with environmental monitoring performance qualification.
• Experience with aseptic processing operations.
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across functions and within multiple stakeholders.
• Excellent oral and written communication skills with strong technical writing experience.
• Comprehensive knowledge of global cGMP regulatory requirements for biologics, cell, and gene therapy products.

Nice To Haves

• Bachelors degree or higher in Microbiology, Biology, Life Sciences, or a related field.
• 10 years of pharmaceutical industry experience, with a minimum of 3-5 years in managing EM/Microbial Contamination Control programs.
• Demonstrated ability to perform long-term project planning, team building, budgeting, and operational excellence.
• Experience with regulatory and/or client audits.
• Knowledge and familiarity with USP<71>, Annex I, and FDA Guidance for Industry - Sterile Drug Products.
• Proven record of building high-performing teams and developing talent.
• Experience with the presentation of validation strategies and execution to auditors and inspectors.
• Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders.
• Ability to collaborate and manage conflict in a fast-paced environment, working across functions.
• Excellent interpersonal, verbal, and written communication skills.
• Experience in application of lean methodologies and operational excellence to continuously improve.

Responsibilities

• Accountable for the development and lifecycle management of the Environmental Monitoring (EM) program, including but not limited to facility and utilities environmental performance qualification, routine monitoring, data trending, EM excursion investigations.
• Develops user requirements and contributes to the selection and implementation of the electronic tools for managing the EM program and laboratory notebooks.
• Responsible for the development and lifecycle management of site specific standard operating procedures related to microbial contamination controls.
• Accountable for the development and lifecycle management of all Microbiology methods, inclusive of method qualification, approval, and execution.
• Establishes requirements and develops on-the-job-training plans for the QC Microbiology team.
• Ensures personnel are qualified and proficient with applicable GMP requirements and internal governing procedures.
• Acts as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological testing.
• Ensures compliance of selected QC laboratory equipment to Part 11 and Data integrity regulations and guidelines.
• Schedules, reviews data and oversees microbiological testing of materials, intermediates and drug products.
• Ensures timely completion of testing deliverables in accordance to commitments made to Clients and corresponding Quality Agreements.
• Provides input and manages execution of method validation and verification for microbiological testing conducted at the site.
• Lead site QC team while supporting individual development and managing performance.
• Develops and manages departmental goals and corresponding budget in alignment with the corporate and site goals.
• Support additional Quality initiatives, as needed.

Benefits

• Resilience offers employees a robust total rewards program including 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees