Singota Solutions
JD212
Job title: Microbiology Supervisor
Department: Quality Control and Development
Location: Bloomington, IN
Position Type: Full-time, 40 hours/week, Exempt.
General Description:
The role of the Microbiology Supervisor includes the following key functions carried out in according to the company vision, mission, standards, goals, objectives, and strategic direction:
· Leads the daily operations of the QC Microbiology functions for Singota
· Works with QC/DEV Leadership, Business Development, and Project Management to manage client opportunities
· Works with inter-department teams to further company goals
· Mentors scientists and is invested in continuing education for team
1. Leads the daily operations of the QC Microbiology (Micro) functions for Singota
· Drives fundamental innovative improvements in development and test processes to reduce cost and lead times and improve throughput / yield.
· Develops and executes microbiological method evaluation, development, qualification, and validation protocols.
· Manage the Environmental Monitoring program associated with the classified areas.
· Manages Micro staff, scheduling, and training.
· Review and support the batch release process through review of environmental and lab data.
· Manages final microbiological product testing of both Singota and non-Singota manufactured products.
· Summarize laboratory findings and document in formal microbiological method s.
· Develops and refines tools, systems, SOPs, and processes.
· Mentors scientists and is invested in continuing education for the team.
· Reviews purchasing of supplies for media fills, routine Micro testing, and third-party MIR testing.
· Works with and supports the QC Chemistry and Formulation Development programs through data review, sharing resources, and collaboration on overlapping projects.
· Mentors scientists on aseptic technique and bioanalytical methods applicable to parenteral product testing and handling, including bioburden and sterility.
2. Works with team to manage client opportunities
· Maintains awareness of industry technical trends and application for innovative techniques.
· Aligns micro capabilities with industry needs and technological advancements.
· Supports Business Development and Project Management groups in writing, planning and executing Development and QC projects for clients.
· Provides timely and accurate communications/updates to Project Managers, BD, or Management.
· Supports client/regulatory visits and audits of the laboratory.
· Regarded as Subject Matter Expert within the microbiological quality control arena.
3. Works with inter-department teams to further company goals
· Periodically summarize status on client or internal testing/work to company.
· Represent QC/DEV on various company/client projects and at technical meetings, as needed.
· Leads in training of new QC/DEV staff to increase team strength and flexibility.
· Support QA by being a SME for laboratory related vendor audits.
· Takes active role in probing and identifying areas for improvement and then implementing solutions.
· Promotes a highly professional working environment within and outside the company.
· Actively promote and engage in effective teamwork between operating groups, collaborating with other managers and directors to lead the company towards meeting its goals and objectives.
4. Mentors scientists and is invested in continuing education
· Mentor microbiology scientists on analytical and bioanalytical methods applicable to parenteral product development, including bioburden, sterility, anti-microbial testing, and other compendial tests.
· Participates and is an advocate in training of new QC/DEV staff to increase team strength and flexibility.
· Support QA by being a SME for microbiology related vendor audits.
· Promotes a highly professional working environment within and outside the company.
· Actively promote and engage in effective teamwork between operating groups, collaborating with other managers and directors to lead the company towards meeting its goals and objectives
Characteristics required include:
1. Strong interest and commitment to exceptional customer service and teamwork.
2. Highly motivated- independent and self-directed work ethic; good judgement and strong decision-making skills; driven to continuously improve.
3. Excellent interpersonal skills-respected by others with an ability to lead and influence; positive and action-oriented; high degree of personal integrity and accountability; ability to communicate effectively and professionally across various audiences and organizational levels.
4. Positive attitude and good judgment – reflective of company values.
5. Technical knowledge base.
6. Excellent time management, organization skills, and ability to manage multiple priorities with high attention to detail in a fast-paced, deadline driven, work environment.
7. Excellent communication and presentation skills – oral and written.
8. Ability to travel to client sites, audits, and trade shows.
9. Ability to problem solve and resolve issues and conflicts.
Work Experience & Educational Requirements:
Singota Solutions is an Equal Opportunity Employer
Job Type: Full-time
Benefits:
Schedule:
Education:
Work Location: One location
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