ManpowerGroup Senior Manager, Quality Control - Microbiology in Bedford, Massachusetts
RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients' lives.
Position Summary & Role:
This role is accountable for developing, implementing and managing the microbial contamination control program and microbial testing at the manufacturing plant located in Bedford, MA. This is an exciting opportunity to contribute to the buildout and qualification of a new manufacturing facility for cell therapy, establishing a robust and comprehensive environmental monitoring program and managing the microbiology testing of materials, intermediates and drug products. The Sr. Manager, Quality Control - Microbiology reports to the Site Quality Head. The position will be located in Bedford, MA.
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.
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
Develops and manages departmental goals and corresponding budget in alignment with the corporate and site goals
Bachelor's degree or higher in Microbiology, Biology, Life Sciences or related field
Minimum of 10 years of pharmaceutical industry experience, with minimum of 5 years in managing Environmental Monitoring (EM)/Microbial Contamination Control programs
Comprehensive knowledge of global GMP regulatory requirements for biologics, cell and gene therapy products
Experience with managing EM programs and drug product microbiological testing is required
Experience with aseptic processing operations is preferred
Experience with environmental monitoring performance qualification is required
Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence
Other Ideal Personal Characteristics:
Proven record of building high performing teams and developing talent
Experience with 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-pace environment, working across functions
Excellent interpersonal, verbal and written communication skills
Experience in application of lean methodologies and operational excellence to continuously improve
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
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