The basic function of the External Project Group Leader is to interact with clients and develop testing schemes for novel testing approaches and special project outside of the scope of routine microbiological testing according to FDA, cGMP and Standard Operating Procedures.
In addition, the Group Leader mentors, trains and supervises the Microbiologists in their group. The essential duties and responsibilities of this position include the following. Other duties may be assigned as needed.
Primary Duties and Responsibilities
- Interacts with clients through virtual or onsite technical meetings in order to understand the scope of the project proposed.
- Estimates the time and materials required to complete these activities and communicates that information to the quoting team.
- Establishes testing timelines and expectations and communicates them to the Internal Project Group Leader for project execution.
- Serves as a technical writing expert in protocol design and final report writing.
- Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
- Coordinates the scheduling of personnel to maximize productivity.
- Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with chemists and laboratory management.
- Coordinates and communicates delays and technical issues with management in a timely manner.
- Maintains and performs the peer review process in support of client and laboratory quality objectives.
- Devises and develops processes and methods for the solution of technical problems.
- Performs system maintenance and calibration to ensure equipment is operating within specified requirements.
- Trains, mentors and supervises Microbiologists in their group.
- Reviews lab investigations and deviations with microbiologists in their group. Conducts root cause analysis and implements solutions in collaboration with the chemists.
- Confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
- Ensures all work performed is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.
Qualifications include a Master’s and/or Bachelor’s degree in Microbiology or a related discipline required with a minimum of 4+ years of industry experience. Knowledge of cGMPs and related compliance regulations and guidance’s required.