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Microbiology Assistant Manager Dynamic Biologics Lillington, NC Job Details Full-time 7 days ago Benefits Health insurance Dental insurance Paid time off Vision insurance Qualifications USP standards Team leadership Good documentation practices (GDP) Corrective and preventive actions (CAPA) GMP Personal protective equipment (PPE) adherence Managing laboratory teams Supervising experience Pharmaceutical company experience Leading team collaboration initiatives Media preparation Safety equipment Microbiological analysis Microbiological testing for sterile processing Regulatory audits Standard operating procedures (SOPs) Manufacturing company experience Full Job Description Ø The Assistant Manager supports the Microbiology Department in overseeing microbial testing, environmental monitoring, and sterility assurance. This role requires hands-on technical expertise, regulatory oversight, and team leadership. Job Responsibilities Ø Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion. Ø Supervise microbiology analysts, and lab Assistants. Handle training and scheduling. Ø Oversee routine testing, including sterility tests, bacterial endotoxin tests (BET), bioassays, and bioburden evaluations. Ø Manage cleanroom and facility environmental monitoring programs (air, water, and surface testing). Ø Ensure adherence to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and USP guidelines. Assist with internal and external regulatory audits. Ø Support the Manager for non-conformance investigations, laboratory deviations, out-of-specification (OOS) results, and corrective and preventive actions (CAPAs). Ø Prepare and Review Standard Operating Procedures (SOPs), validation protocols, and test reports. Ø Monitor and Performs trend analysis of microbiology test results. Ø General procedural functions include Procures supplies for the microbiology laboratory; monitors housekeeping; disposal of laboratory wastes, Biohazard waste and other microbiological laboratory chemicals, samples and materials. Ø Responsible for monitoring activities like Media preparation: sterilization of waste and glassware, instrument calibration/maintenance/daily monitoring, and quarterly inventory report. Ø Follows strict "good documentation practices" per company's SOP's and cGMP regulations. Ø Adheres to safety rules and awareness, always demonstrates good safety practices, takes initiative to report and correct safety hazards. Uses Personal Protective Equipment (PPE) associated with assigned tasks. Ø The nature of the QC laboratory requires that individuals are interested and motivated to participate in a team working concept. The Assistant manager must routinely interact with various company departments and therefore good interpersonal skills are necessary to effectively perform the job function. Ø Works as a member of a team to achieve all outcomes. Ø To provide necessary support and inputs to R & D during product/process development, technology transfer and new product launches. Ø All other relevant duties as assign. Qualifications & Requirements

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Education:

Bachelor's or Master's degree in Microbiology, Biology, Biotechnology, or a related life science.

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Experience:

10+ years of microbiology laboratory experience within the pharmaceutical, biopharmaceutical, or regulated medical device industry, including 1 to 2+ years in a supervisory or leadership role.

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Technical Skills:

Strong working knowledge of USP, EP, and JP pharmacopeial methods, sterility assurance, and equipment validation

Physical Requirements:

Ability to wear proper personal protective equipment (PPE) such as lab coats, gloves, and safety glasses for extended periods.

Required to stand, walk, sit, talk and hear; required to use hands to operate vehicles and office equipment; must be able to occasionally lift and/or move up to 50 lbs; specific vision requirements for this job include: close, distance and peripheral vision, and the ability to adjust focus, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position without compromising patient care. KriGen Pharmaceuticals LLC dba Dynamic Biologics is an equal opportunity employer. All employment decisions are made without regard to age, color, race, ancestry, national origin, disability, genetic information, military status, religion, creed, sex, pregnancy, childbirth, marital status, citizenship, sexual orientation, gender identity, gender expression, legally protected medical condition, or any other basis prohibited by applicable law. Background checks and drug screens are part of our hiring process. Affirmative Action/Equal Opportunity Employer, Minority/Female/Disabled/Veteran.

Benefits:

Dental insurance Health insurance Paid time off Vision insurance Application Question(s): What is your salary expectations? Bachelor's or master's degree in microbiology, Biology, Biotechnology, or a related life science. Atleast 10 years of experience in the microbiology laboratory experience in pharmaceutical/ biopharmaceutical/ regulated medical device industry, including, 1 to 2+ years in a supervisory /leadership role.

Work Location:

In person