Microbiologist II

East Windsor, NJ - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

POSITION OVERVIEW:
The Microbiologist II plays a key role in advancing microbiological quality by performing complex testing supporting method development and validation and leading critical investigations to ensure regulatory compliance and product integrity. This position may also mentor junior team members oversee aspects of environmental monitoring and contribute to continuous improvement across laboratory operations. Through scientific excellence and operational leadership the Microbiologist II directly supports our mission to expand access to affordable innovative medications that are safe effective and life-enhancing.

ESSENTIAL JOB FUNCTIONS:

Conducts microbiological sampling and testing of raw materials finished products and environmental monitoring samples using methods such as bioburden sterility endotoxin and total organic carbon while adhering to International Organization for Standardization cleanroom protocols involving gowning and routine sample handling.
Leads or actively contributes to laboratory investigations including growth promotion microbial enumeration identification antimicrobial effectiveness testing root cause analysis and impact assessments for Out of Specification or Out of Trend results and proposes or implements effective corrective and preventive actions.
Supports or executes the development validation and transfer of microbiological test methods including protocol drafting execution and data interpretation in collaboration with Quality Control and Research & Development teams.
Accurately documents procedures results and observations in compliance with laboratory protocols safety guidelines and regulatory standards including current Good Manufacturing Practices (cGMP) while supporting data trending change control documentation and maintaining laboratory equipment.
Collaborates across functions and mentors junior staff as needed communicating technical findings clearly and participating in research discussions project meetings and continuous improvement initiatives.

QUALIFICATIONS:

Minimum of 3 years of microbiology experience in a regulated laboratory setting is required; pharmaceutical compounding or aseptic experience strongly preferred.
Bachelors degree in microbiology biology biochemistry or a related scientific field required; advanced coursework or relevant certifications preferred.
Proficiency in microbiological testing techniques method development and validation and environmental monitoring with working knowledge of compendial methods bacterial endotoxin testing sterility microbial limit testing and regulatory standards including United States Pharmacopeia Food and Drug Administration and cGMP.
Strong analytical and problem-solving skills with the ability to work independently and collaboratively prioritize evolving workloads and communicate effectively in both written and verbal formats.

KEY COMPETENCIES:

Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
Optimizes Work Processes: Know the most effective and efficient processes to get things done with a focus on continuous improvement.
Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
Resourcefulness: Secures and deploys resources effectively and efficiently.
Manages Complexity: Makes sense of complex high quality and sometimes contradictory information to effectively solve problems.
Ensures Accountability: Holds self and other accountable to meet commitment.
Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

VALUES:

People: Our people define who we are as a company and we believe that understanding and addressing the needs of our team clients and community is fundamental to fostering a culture of support and growth.
Quality: Quality stands at the core of our mission reflecting our commitment to excellence in every medication we produce.
Service: We are here to serve others. Every interaction with our patients providers employees and other stakeholders comes from a place of service.
Innovation: By continuously exploring new methodologies and embracing technology we ensure that every solution we offer is at the forefront of pharmaceutical care.

SUPERVISORY RESPONSIBILITIES:
This position does not have supervisory responsibilities.

CERTIFICATES LICENSES REGISTRATIONS:
Registered Microbiologist (RM) through the National Registry of Certified Microbiologists preferred; Certified Quality Auditor (CQA) through the American Society for Quality preferred;
Other industry-recognized microbiology or quality certifications are considered a plus.

Important Notice: Protecting Your Information
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Required Experience:

Manager

POSITION OVERVIEW:The Microbiologist II plays a key role in advancing microbiological quality by performing complex testing supporting method development and validation and leading critical investigations to ensure regulatory compliance and product integrity. This position may also mentor junior tea...

Conducts microbiological sampling and testing of raw materials finished products and environmental monitoring samples using methods such as bioburden sterility endotoxin and total organic carbon while adhering to International Organization for Standardization cleanroom protocols involving gowning and routine sample handling.
Leads or actively contributes to laboratory investigations including growth promotion microbial enumeration identification antimicrobial effectiveness testing root cause analysis and impact assessments for Out of Specification or Out of Trend results and proposes or implements effective corrective and preventive actions.
Supports or executes the development validation and transfer of microbiological test methods including protocol drafting execution and data interpretation in collaboration with Quality Control and Research & Development teams.
Accurately documents procedures results and observations in compliance with laboratory protocols safety guidelines and regulatory standards including current Good Manufacturing Practices (cGMP) while supporting data trending change control documentation and maintaining laboratory equipment.
Collaborates across functions and mentors junior staff as needed communicating technical findings clearly and participating in research discussions project meetings and continuous improvement initiatives.

QUALIFICATIONS:

Minimum of 3 years of microbiology experience in a regulated laboratory setting is required; pharmaceutical compounding or aseptic experience strongly preferred.
Bachelors degree in microbiology biology biochemistry or a related scientific field required; advanced coursework or relevant certifications preferred.
Proficiency in microbiological testing techniques method development and validation and environmental monitoring with working knowledge of compendial methods bacterial endotoxin testing sterility microbial limit testing and regulatory standards including United States Pharmacopeia Food and Drug Administration and cGMP.
Strong analytical and problem-solving skills with the ability to work independently and collaboratively prioritize evolving workloads and communicate effectively in both written and verbal formats.

KEY COMPETENCIES:

Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
Optimizes Work Processes: Know the most effective and efficient processes to get things done with a focus on continuous improvement.
Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
Resourcefulness: Secures and deploys resources effectively and efficiently.
Manages Complexity: Makes sense of complex high quality and sometimes contradictory information to effectively solve problems.
Ensures Accountability: Holds self and other accountable to meet commitment.
Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

VALUES:

People: Our people define who we are as a company and we believe that understanding and addressing the needs of our team clients and community is fundamental to fostering a culture of support and growth.
Quality: Quality stands at the core of our mission reflecting our commitment to excellence in every medication we produce.
Service: We are here to serve others. Every interaction with our patients providers employees and other stakeholders comes from a place of service.
Innovation: By continuously exploring new methodologies and embracing technology we ensure that every solution we offer is at the forefront of pharmaceutical care.