QC Manager, Microbiology

Summary

The QC Microbiology Manager manages the day to day operations of the QC Microbiology laboratory including managing QC Microbiology associates, making tactical decisions that ensure the required testing and reporting is on time and accurate.

PRINCIPAL Responsibilities

* Responsible for the oversight of product testing as related to microbiological assays
* Responsible for the oversight of environmental and utility monitoring and related testing
* Responsible for the oversight of testing for cleaning verification program and oversees related equipment validation
* Represents Microbiology in cross-functional teams and investigations. Communicates clearly, efficiently and accurately with internal groups and external groups (vendors, clients, etc)
* This position will support and provide oversight and preparation of Annual EM, deviation and other applicable investigation reports

Knowledge, Skills & Abilities

* Requires knowledge of environmental and utility monitoring program design, compendial microbiological testing (bioburden, endotoxin, etc.), microbial identification, TOC and conductivity testing, investigations and report writing
* Experience in lab supervision
* Good organizational skills and attention to detail
* Excellent communication and verbal presentation skills

Education/Experience

* A minimum of 8+ years QC related experience
* BS/BA degree required in Microbiology or Biology
* Minimum of 2+ years of managerial experience preferred
* Experience with GMP biologics manufacturing and related regulatory requirements including USP and EP.
* Strong understanding of Microbiology and Facility testing (e.g. TOC.)
* Ability to understand and evaluate analytical/technical data.
* Experience with relevant analytical lab equipment and computers.
* Clear, concise writing skills.
* Fluent in communicating (written and verbal) in English.
* Knowledgeable in Microsoft Excel and Word.

Annual Compensation Range: $112,583-$135,100

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.