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Resilience · 20 hours ago

Director, Quality Control Microbiology

East Norriton, PA

Full-time

Onsite

Director/Executive

$160K/yr - $228K/yr

10+ years exp

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Director, Quality Control - Microbiology is responsible for developing and managing the microbial contamination control program and microbial testing at the manufacturing plant, ensuring compliance and overseeing the QC Microbiology team.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical

No H1B

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

Qualification

Environmental Monitoring programsMicrobial Contamination ControlAseptic processing operationsCGMP regulatory knowledgeTechnical writingTeam buildingProject planningLean methodologiesInterpersonal skills

Required

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