Scientist II, Micro Support, MSAT

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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

This position will serve as the technical expert for the Technology Transfer Process for Microbiology Lab methods, site contamination control and serve as a liaison between the client, the Microbiology lab, and the operations department at the West Chester site to ensure compliance with global standards, regulations, and cGMPs. In addition, this role 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.

Job Responsibilities

Partner with the Microbiology lab and Aseptic Control team to develop and maintain processes and systems.

Serves as the technical leader for MSAT on Microbiology methods and processes.

Partners with Micro to train the team on new procedures, and/or processes.

Develop or Support transfer, development and qualification of new methods and processes.

Answer compliance and process questions from others, including regulatory agencies.

Facilitates and leads initiatives using new technologies, new policies, or new procedures to improve Micro functions.

Liaison between the client, operations, and QC operations team during the tech transfer phase.

May serve as primary contact for contract services including 3rd party laboratory testing during the Tech Transfer phase.

Serve as SME for certain microbiology techniques/instrumentation/equipment/procedures.

Serve as SME for the implementation and lifecycle management of Contamination Control program.

Supporting manufacturing sterility investigations (example: aseptic process simulations, drug product sterility testing, and other microbial excursions).

Championing sterility assurance principals at the site and serving as one of the site's microbial controls technical leader in the areas of aseptic processing and contamination control.

Support the site in the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.

Ensure alignment and harmonization regarding global microbiological/aseptic standards and compendial/regulatory requirements.

Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial/viral controls.

Support site microbial and cross contamination LOPA and HACCP risk assessments

Lead efforts, in collaboration with other site and company experts, to ensure compliance and adequate cleanroom design, airflows, traffic flows, cleaning and disinfection, aseptic gowning, aseptic techniques and behaviors.

Minimum Requirements
Extensive experience in pharmaceutical, food or related industry
Proven proficiency in solving complex technical problems
Demonstrated knowledge of cGMP as defined by 21CFR, Combination Drugs and EU Regulations
Experience with method validations or method transfers

Experience with sterility, bioburden and endotoxin testing
Ability to demonstrate understanding of Micro laboratory regulatory issues
Proficiency with microbiology laboratory instrumentation
Strong technical writing skills and proficiency with MS Word and Office
Experience with coaching, mentoring and training analysts.

Preferred Background
Bachelor's degree or higher Microbiology, or a related field

> 10 years experience in a Microbiology laboratory
Strong project management skills

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

Experience/familiarity in contamination control strategy

Experience/familiarity in particulate control and troubleshooting

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

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.