Senior Microbiologist - Katalyst Healthcares & Life Sciences
Ridgefield, NJ 07657
About the Job
Responsibilities:
- Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.
- Validation protocol writing, review, and execution (or over seeing validation execution).
- SOP review, creation, and approval.
- OOS investigations writing/review and approval.
- Mentor junior Analysts on testing, trouble shooting and Lab related items.
- Ensure compliance with all cGMP standards, safety and environmental regulations and company SOPs.
- Provide advice to subordinates based on general policies and management guidance.
- Ensure that high level projects are completed on schedule and accurately.
- Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data.
- Participates in Change Control meetings as the Microbiology Subject Matter Expert and initiates change controls as required.
- Support regulatory, third party and internal audits when required.
- Conveys complex information in a concise manner
- Motivate and Develop teams.
- Interact with Project Teams and cross-functional groups related to site operations.
- The candidate must have previous quality control microbiology experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, endotoxin assays.
- Act for Change: Embrace change and innovation and initiate new and improved ways of working.
- Cooperate transversally: Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results.
- Develop People: Take responsibility for developing oneself and mentor other Micro Personnel in anticipation of future business needs or to assist the micro department.
- HSE.
- It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.
- The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations.
- Individuals must complete all required HSE training.
- Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.
- Physical Requirements include the capacity to lift and carry up to 20 pounds, kneel, reach and stretch, and to stand for at least 4 hours.
- BA/BS in Microbiology/Biology with 6-10 years' experience is required.
- A thorough understanding of validation testing; write, execute and report validation studies.
- Practical experience in general microbiology laboratory techniques working with bacteria, yeast and Mold.
- Prior experience with, writing protocols, data review, authoring SOPS, Change Controls, out of specification investigations and report writing.
- Excellent technical writing skills.
- Ability to collaborate effectively with personnel and between departments.
- Strong analytical and problem-solving skills.
- Make sound judgement from data.
- Works independently.
- Working knowledge of Word, Excel, and PowerPoint.
- Preferred experience with a deviation/CAPA enterprise system.
Source : Katalyst Healthcares & Life Sciences
