Lonza Site Microbiologist Post Vacancy 2021 – Candidates Apply Online
Lonza is a global leader in life sciences operating across three continents. While they work in science, there’s no magic formula to how they do it. Their greatest scientific solution is talented people working together, devising ideas that help businesses to help people.
Job Title: Site Microbiologist
Job Location: United States, Houston (Texas)
This role represents the site and the Quality Control department as the subject matter expert for Microbiological methods. The individual in this role will be responsible for managing department leads and analysts, representing the site in client interactions, directing complex special projects, performing risk assessment, guiding/supporting OOS investigations, leading Microbiological assay qualifications, implementing new methods, and implementing strategies for the QC Microbiology department.
Eligibility Criteria & Skills Required:
- Ph.D. in Microbiology/Biotechnology required
- MsC a plus
- NRCM certification preferred
- Advanced years of experience in QC Microbiology and cGMP environment
- Must have strong communication skills, both written and oral. In addition, must have proficiency in Microsoft Word and Excel. Experience with microbiological assay
- qualifications and associated regulatory/compendial guidance documents (FDA, USP, EU, etc.)
- Demonstrated knowledge in laboratory skills, microbiological assays, and aseptic test methods. Demonstrated knowledge of cGMP and regulatory requirements.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Prior experience with WinKQCL, LIMS, MODA, TrackWise, and SAP a plus
- Able to problem solve within QC Microbiology with little to no support and limited direction. Performs root cause analysis, and drives process improvement events where needed.
- Provides solutions for the improvement of documentation and workflows.
Has the ability to integrate scientific data from multiple complex assays and make quality decisions based on the available data.
- Writing is clear, concise, and free of punctuation, spelling, and grammatical errors
Provides timely, clear, and accurate updates without being prompted.
Records assay qualification and test results and maintains raw data and accurate laboratory records.
- Able to work well within and coordinate a team. Capable of effectively representing the department in meetings, audits, and on project teams.
- Leads by example and offers guidance to co-workers with respect to compliance and personal interactions.
- Owns and implements process improvements.
- Is optimistic and display a positive attitude even during periods of adversity.
Owns specialized tasks with little direction.
- Is considered a go-to person for assistance.
- Willing to pursue opportunities that can lead to substantial benefit, even if there are risks involved.
- Champions change by speaking positively to and about others in all situations.
- Develops assay qualification strategies and methods for bioburden, endotoxin, Mycoplasma, and sterility testing.
- Performs and directs risk assessments for microbiological processes.
- Interprets data and recommends solutions/best practices.
- Assists with strategy implementation for the laboratories, supplies, and equipment.
- Provides technical oversight for investigations for OOS excursions and deviations.
- Performs statistical analysis and provides oversight for the generation of summary reports or white papers/rationale documents.
- Writes and revises procedures and qualification reports through change control.
Leads, mentors, and coaches staff through routine one-on-one meetings, team meetings, and effective performance management. Sets and delivers on individual and team goals that support the department and site strategy. Takes personal accountability for both his/her own and the team’s actions.
- Maintains compliance with all required training and assists with training of direct reports.
- Serves as a technical SME for other site groups.
- Represents QC Microbiology when interacting with clients or auditors.
- Performs other duties as assigned.
Lonza Site Microbiologist Post