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:

The Scientist I, QC Microbiology, performs project work and leads laboratory investigations. Participates in investigations for Manufacturing process areas, related to QC processes or data. Troubleshoots methods and processes. Verifies QC data, while monitoring for trends and abnormalities. Leads technology transfer of Microbiology methods and owns related change controls and protocols for new methodology.

Position Responsibilities:

• Act as SME for testing on a range of samples, finished products and stability samplesincluding sterility, endotoxin, and CCI

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

• Author trend reports, such as utilities and lab results trending

• 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.

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

• Develops and validates new methods and processes

• Leads new method verification and technology transfer activities related to Microbiology Lab testing

• Lead new lab equipment validations as Microbiology SME

• Interact with applicable regulatory agencies during site inspections, acting as area SME

• Implement changes related to regulatory updates from USP, Ph. Eur., etc.

• Own and manage change control, deviation, and CAPA records

• 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 laboratoryinstrumentation.

• 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.

• 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 laboratory experience

This position may also include the following conditions:
This role is primarily sedentary and requires visual acuity (such as viewing computers, extensive reading).

Quality Statement: All employees are expected to adhere to the quality management system established in the Quality Manual, Quality Policy, SOPs, cGMP, and any other applicable regulations and standards to the details 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.