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
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.
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
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
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.
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
Bachelor’s degree or higher Microbiology, or a related field
> 10 years experience in a Microbiology laboratory
Strong project management skills
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.
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. Our target base pay hiring range for this position is $95,000.00 - $136,250.00 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.
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