Scientist I, QC Microbiology

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 & Responsibilities:
Participates in investigations for Manufacturing process areas, related to QC processes or data. Trains QC employees. Troubleshoots methods and processes. Performs testing of samples. Verifies QC data, while monitoring for trends and abnormalities. Performs project work and leads laboratory investigations. Develops methods and processes. May serve as the primary link between QC team and QC Microbiology Manager, for day-to-day activities, such as schedules and workload planning. Coordinates workflow in QC microbiology team. Serves as technical SME for new and existing Microbiology methods.

• Coordinate workflow and assign work tasks and activities to others

• Performs sampling and testing on a range of samples, finished products and stability samples

• Verifies and approves QC data, while monitoring for trends and abnormalities. Reports, and acts on data results.

• Serves as QC lead for investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling and testing.

• Leads project work and investigations.

• Serves as the technical leader in the laboratory.

• Serve as SME (subject manager expert) for certain microbial techniques/instrumentation/equipment/procedures

• Develops and validates new methods and processes.

• Assist in the development of QC Microbiology analysts and technician through mentoring and training.

• May serve as primary contact for contract services, including laboratory testing.

• May serve as designee, such as delegation of authority (DOA) for Manager, QC Microbiology.

Minimum Qualifications:

• Significant experience in a sterile manufacturing pharmaceutical laboratory.

• Proficiency with  instrumentation including isolator.

• Working knowledge of cGXP requirements and a strong familiarity with production operations.

• Proven proficiency in solving complex problems and elucidating root causes for investigations

• Strong technical writing skills, proficiency with MS Word and Office

• Previous experience coaching and mentoring peers.

• Working knowledge of MODA, Novatek, or equivalent sampling and testing software.

• Working knowledge of laboratory sample management systems, such as LIMS or LabVantage

• Working knowledge of change and deviation management systems

• Strong familiarity with USP and EP as it pertains to Microbiology

Preferred Qualifications:

• Bachelor’s degree in microbiology (or closely related subjects)

• Higher level degree in Microbiology

• Extensive QC pharmaceutical Microbiology laboratory experience

This position may also include the following conditions:

1. Physical work - This role is primarily sedentary, but infrequent lifting, standing, walking, bending, stooping, reaching, repetitive motion, noise exposure, visual and auditory acuity, and wearing personal protective equipment are required.

2. Quality Statement: All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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.

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