QC Microbiology Group Leader

Job Description

Position Responsibilities:

The QC Microbiologgists are responsible for leading the key operational aspects of the QC Microbiology laboratory at our client site. These positions perform and train others on the microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples. These positions primarily work independently with minimal supervision as needed, acting in consultation with client management for all decisions.

This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory so there will be flexibility in job roles. There may be the opportunity to write or assist with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting client management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.

Key Responsibilities:

Ensure adherence to highest quality and efficiency standards in laboratory operations. Ensure cross training initiative are in place and followed.

Lead by example. Demonstrate by words and actions what it is to be a successful ELLI PSS employee. Demonstrate willing to do what is necessary for the program to be successful. Demonstrate through word and actions that we are part of the team.

Foster morale and teamwork. Ensure the reward and recognition programs are utilized to the fullest. Ensure systems are implemented at the site to foster team morale.

Develop and maintain effective, trusting work and customer relationships. Build loyal customer relationships. Meet with Client's on a regular basis.

Lead team, schedule, and train employees in client environment

Ensure adherence to highest quality and efficiency standards in laboratory operations

Ensure coverage and performance

Foster morale and teamwork

Performing advanced lab testing and support for all laboratory assays for all samples

Leading sample collection and managing sample logistics for testing

Supporting testing for all qualification and study directed testing

Leading sterility testing

Reviewing intermediate lab testing results

Acting as qualified trainer and SME of at least one test

Troubleshooting complex assays

Assisting with writing of documents. Reviews and edits documents

Supports investigation of routine OOS assays and events

Embraces LEAN lab and six sigma principles and applies them to laboratory processes