Microbiologist / Pharma Manufacturing

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.

The Analyst II, QC Microbiology role supports the Microbiology Department by performing quality-related tasks for pharmaceutical products to include documenting and conducting testing on a variety of samples, such as raw materials, in-process and finished products, stability samples, water, gas, and environmental samples.

Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.

Complete required training and may train others.

Actively participates in investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling, and testing.

Identifies trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.

Demonstrates proficiency on authoring Quality records (Deviations, CAPAs, and Change Controls).

Identify temporary and permanent fixes to address issues.

Monitor equipment and/or systems for performance and problem indicators.

Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.

Lead or participate in process improvement activities and teams to meet strategic goals.

Interact with regulatory agency individuals during audits and inspections, when necessary.

Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product.

Perform routine sampling activities on the facility utilities.

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

Bachelor's degree in biology, microbiology, or related discipline.

At least 2 year of laboratory experience in pharmaceutical industry.

Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment.

May include but not limited to standing, walking, repetitive motion, and chemical usage.

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.

Sponsorship or support for work authorization, including visas, is not available for this position.

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. 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, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

Our target base pay hiring range for this position is $60,000.00 - $86,250.00 per year.