Senior Microbiologist - Virginia

Novo Nordisk•Petersburg, VA

8d•Onsite

About The Position

Responsible for ensuring the sterility and quality of pharmaceutical products by performing microbiological tests on raw materials and, manufacturing environments and finished products throughout the production process, identifying potential microbial contamination and maintaining compliance with regulatory standards to guarantee patient safety. About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

Requirements

Bachelor’s degree in microbiology or science related field from an accredited university required and a minimum of six (6) years of experience performing routine and non-routine microbiological assays on raw materials, water, in-process samples, packaging materials and finished products or related experience required
In lieu of Bachelor’s degree and six (6) years of experience, may consider an Associate’s degree in microbiology or related field from an accredited college with minimum of eight (8) years of experience performing routine and non-routine microbiological assays on raw materials, water, in-process samples, packaging materials and finished products or related experience required
In lieu of Bachelor’s degree and six (6) years of experience, may consider a High School Diploma/GED with a minimum of ten (10)) years of experience performing routine and non-routine microbiological assays on raw materials, water, in-process samples, packaging materials and finished products or related experience required
Strong understanding of microbiology principles, including microbial identification, culture techniques and sterilization methods required
Experience with GMP regulations and quality control procedures required
Proficiency in laboratory techniques such as aseptic technique, microbial enumeration and molecular biology methods required
Excellent analytical and problem-solving skills required
Detail-oriented with strong documentation and record-keeping abilities required
Ability to work independently and as part of a team required
Excellent communication skills to effectively report findings and collaborate with other departments required
Ability to set scientific direction and mobilize a project work and activities required
Good collaboration skills with and interaction with many departments required

Responsibilities

Perform or oversee routine and non-routine microbiological assays on raw materials, water and release samples to detect the presence of microorganisms
Sample and analyse air, surfaces and water within the manufacturing facility to monitor for microbial contamination
Author, review and approve test methods and standard operating procedures (SOPs)
Perform or oversee validations for new equipment and test methods
Author, review and approve protocols and reports
Author, review and approve testing requirements or specifications
Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements
Maintain accurate and detailed records of experiments, results and procedures in laboratory notebooks and electronic systems, ensuring data integrity
Perform peer review of laboratory documentation and lab data to ensure compliance with laboratory SOPs and test methods
Isolate and identify microorganisms using various techniques like culture-based methods, molecular biology and automated systems
Provide training and coaching on proper microbiological techniques
Assist peers with troubleshooting general laboratory instrumentation, analysis and methodologies
May serve as process area responsible for lab related systems, software, or processes
Support area process manager (APM) by providing technical expertise on relevant lab related topics
Participate in multidisciplinary project groups
Contribute and lead cLEAN process improvement activities
Support and lead investigations of laboratory samples and help determine appropriate corrective and preventive actions
Support and lead Deviations related to microbial analysis
Oversee and assign general laboratory duties including cleaning and maintenance of equipment, work areas and cleaning of the microbiology laboratory
Support management on setting key performance indicators (KPIs)
Follow all safety & environmental requirements in the performance of duties
Other duties as assigned