Scientist I, QC Microbiology

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Job Overview

The position of Scientist I, QC Microbiology at Resilience provides an excellent opportunity for individuals looking to make a significant impact in the biomanufacturing sector. Resilience is a forward-thinking biomanufacturing company aimed at innovating the way medicine is created, and this role is integral in maintaining high-quality standards within quality control (QC) processes.

Company Profile

Resilience is a technology-focused biomanufacturing entity committed to building a sustainable network of high-tech manufacturing solutions. The company's goals include creating robust systems that can withstand disruptive events, which enhance scientific discovery and ensure the welfare of those in need. Resilience takes pride in its mission of delivering transformational solutions to the healthcare industry.

Position Summary

As a Scientist I in QC Microbiology, the professional in this role will be responsible for leading laboratory investigations, performing project work, and supporting investigations related to manufacturing processes. The position includes critical responsibilities such as troubleshooting methodologies, verifying QC data while monitoring for trends and abnormalities, and leading technology transfers of microbiological methods.

Key Responsibilities

The main responsibilities for this position include:

  • Acting as a Subject Matter Expert (SME) for testing across a variety of samples, including finished products, stability samples, sterility tests, endotoxin tests, among others.

  • Supervising and approving QC data while identifying trends and abnormalities, and taking necessary actions based on data results.

  • Authoring trend reports involving utilities and lab results trending.

  • Leading QC investigations involving sampling, deviations affecting QC results, investigational sampling, and testing.

  • Serving as the technical leader for investigations and overseeing project work.

  • Developing and validating new methods and leading their verification and technology transfer.

  • Interacting with regulatory agencies during site inspections and implementing changes related to regulatory updates.

  • Managing documentation related to change control, deviations, and Corrective and Preventive Actions (CAPA).

  • Acting as the primary contact for contract services, including laboratory testing when needed.

Required Skills and Qualifications

Candidates for the Scientist I position should possess a robust set of skills and a certain level of experience in a sterile manufacturing pharmaceutical laboratory. Minimum qualifications include:



  • Significant experience in the pharmaceutical laboratory setting.

  • Proficiency with laboratory instrumentation and a thorough understanding of current Good Manufacturing Practices (cGMP).

  • Proven ability to solve complex issues and identify root causes of problems.

  • Strong technical writing skills and proficiency with software tools such as MS Word and Office.

  • Familiarity with laboratory sample management systems like LIMS or LabVantage as well as deviation management systems.

  • Strong understanding of USP and EP standards related to microbiology.

Preferred qualifications are:

  • A Bachelor's degree in microbiology or closely related fields, with higher-level degrees preferred.

  • Extensive experience in a QC pharmaceutical laboratory setting.

Salary Information

The base pay for the Scientist I position at Resilience ranges from $80,000.00 to $117,500.00 per year. The actual salary will depend on various factors, including geographical location and the candidate's relevant experience, qualifications, skills, and knowledge.

Working Conditions

This position primarily requires sedentary work as well as visual acuity for tasks such as extensive reading and screen viewing. Employees are also expected to adhere to the company’s quality management system, which emphasizes compliance with established quality policies, standard operating procedures, and regulatory standards.

Employee Benefits

Resilience offers a comprehensive total rewards program that includes equity options, an annual cash bonus program, a 401(k) plan with a favorable company match, alongside thoughtfully designed benefits. These benefits encompass healthcare options (medical, dental, and vision), family-building benefits, life and disability insurance, flexible time off, paid holidays, and educational support, including tuition reimbursement.

Conclusion

In conclusion, working as a Scientist I, QC Microbiology at Resilience not only offers individuals the chance to engage deeply in the biomanufacturing field but also provides comprehensive support through an array of benefits. Candidates driven by a desire to influence the future of healthcare and backed by the requisite skills are encouraged to apply and pursue this opportunity to become part of a cutting-edge biomanufacturing company.



This job offer was originally published on himalayas.app

Resilience

United States

Software testing

Full-time

February 5, 2025

16 views

3 clicks on Apply Now

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