Objectives/Purpose of Job:Manage the Microbiology Laboratory in the areas of Product and Raw Materials Testing according to established Specifications, Environmental Monitoring and Critical Systems samples and others in agreement with all applicable regulatory requirements.
Supervise technical staff in connection with routine and project related microbiological testing. Work with Manufacturing and other departments to solve and prevent production related problems.
Provide microbiological expertise, including oversight and guidance for site in relation to Microbiological Testing conducted by the Laboratory.
Key Activities/Responsibilities:
- Manage and schedule day-to-day testing within the Laboratory based on Manufacturing and special Project's needs.
- Coordinate with Manufacturing and other departments to solve/prevent production delays.
- Ensure personnel are properly trained/qualified to perform assigned tasks.
- Provide personnel coaching and conduct performance evaluations and personnel to support career development.
- Ensure site and department objectives are communicated and met.
- Work well with Manager in the timely and proper escalation of non-conformances and issues impacting the laboratory, manufacturing and Projects timelines and deliverables.
- Draft and/or approve validation protocols/reports.
- Draft and/or approve Procedures and Protocols for improvement, clarity, corrections, etc.
- Oversee inventory of equipment and supplies to eliminate out of stock situations potentially impacting manufacturing and other Departments.
- Prepare, participate, approve investigations.
- Support Projects, Validation activities, etc. and meet due dates.
- Oversee visual inspection of media fill units for turbidity/microbial contamination.
- Ensure excursions are reported timely, properly investigated within due date window, including identifying effective CAPAs and subsequent implementation to prevent recurrence of similar events.
- Coordinate microbiology data release activities including compilation, review, data entry, etc.
- Understand Team challenges impacting site and Corporate metrics and implement effective changes to reduce errors and continuously improve metric targets.
- Prepare and present trending of applicable Microbiological Data in support of periodic reports and presentation to site Management.
- Represent the Microbiology Department during audits.
- Work effectively with peers and Managers within the Microbiology Department and other Departments.
- Preparation and reporting of site metrics: daily, weekly, monthly, yearly, as well as Ad-Hoc, as needed.
- Implement continuous improvement initiatives within the department to reduce costs, increase compliance, reduce timelines, increase efficiency, etc.
- All other duties as assigned.
Qualifications/Training:- Bachelor's or MS degree in Microbiology, Biology, or related Life Science required.
- Aseptic Manufacturing Facility experience required.
- 7+ years of relevant Laboratory work experience, of which 3+ years must be in a supervisory role.
- Strong leadership skills, time management, planning and organization capabilities.
- Thorough knowledge of compounding, filling (aseptic and non-sterile operations) and packaging processes within the pharmaceutical industry and applicable regulations (e.g. FDA, ISO, MHRA, etc.). Excellent oral and written communication skills.
- Training in aseptic processing and investigational skills a must.
Physical Requirements / Working Conditions:- Ability to lift and/or carry 25 lbs.
- Ability to achieve 20/20 correctable vision.
- Ability to maintain proper personal hygiene.
- Ability to wear laboratory PPE/attire.
- Ability to gown aseptically and work in a controlled environment for extended periods of time (no makeup, jewelry, fingernail polish, etc.)
Required Knowledge, Skills, & Abilities:- Ability to communicate effectively with direct reports, peers, and management.
- Ability to work in a fast-paced environment.
- Ability to work full-time, onsite, including overtime and weekends if necessary to meet department/site objectives.
- Strong leadership, time management, planning, and organizational skills.
- Thorough knowledge of Aseptic Manufacturing processes and applicable regulations (e.g. FDA, USP, ISO, etc.).
- Excellent oral and written communication skills.
- Advanced knowledge of microbiological testing monitoring techniques and skills.
This position may be available in the following location(s): US - Tampa, FL
Our US Benefit Programs Employee Benefits: Bausch + Lomb
