Senior Microbiologist

Reporting to the Manager, Microbiology, the Senior Microbiologist, will be responsible for performing biological assays of raw materials, in-process samples, finished product, and environmental monitoring samples. They will work with the microbiology personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with approved SOPs and regulatory requirements.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Train and mentor analysts in troubleshooting issues related to documentation and testing
• Support the development, verification, and validation of microbiological methods, including sterility, endotoxin, bioburden, AET, biological indicator enumeration and growth promotion testing
• Review microbiological testing records for accuracy and adherence to test methods instrument malfunctions, and methodology problems
• Act as a subject matter expert for microbiology and compliance, supporting deviation investigations, CAPA implementation, and technical audits
• Lead and participate in continuous improvement projects in the laboratory including 5S and inventory management
• Assist in the development and implementation of training programs that govern general and microbiological specific laboratory practices
• Serve as a backup for sampling activities for environmental monitoring and facility utilities

QUALIFICATIONS, KNOWLEDGE, SKILLS, & ABILITIES

• Bachelor’s degree (U.S. or foreign equivalent) in Biology or a related field.
• Seven (7) years of pharmaceutical experience
• Ability to work in a fast-paced environment with minimal supervision
• Able to work flexible schedules at short notice
• Work in a team environment with well-developed interpersonal skills and excellent organizational skills
• Experience with EMPQs and Aseptic Process Simulations
• Familiarity with QMS systems such as Master Control and BMRAM 
• Working knowledge of cGMP, FDA, ICH, USP, and other regional and country specific guidance
• Proficient in Microsoft Word, Excel, Outlook, and PowerPoint

PHYSICAL REQUIREMENTS

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.