Pfizer

Sr. Team Leader - Microbiology

Posted Yesterday

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Vizag, Vishākhapatnam, Andhra Pradesh, IND

In-Office

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Lead and manage microbiology QC teams and shift activities, ensure cGMP compliance, oversee environmental monitoring, cleanroom classification, contamination control and Annex 1 adherence. Drive investigations, CAPA, root cause analysis, risk assessments, trend analysis, regulatory inspection response, equipment and area qualifications, and laboratory technical support while managing multiple projects and developing staff.

Summary Generated by Built In

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. You will play a crucial role in improving patients' lives by ensuring the highest standards of quality and safety in our products. Your leadership will be instrumental in driving innovation and excellence, ultimately making a global impact on patient health.
What You Will Achieve
In this role, you will:

Lead people, technology, and EM team pertaining to the shifts.
Identify and develop innovative concepts for process or product improvements, taking calculated risks to achieve results.
Solve complex problems, leveraging experience from various areas as needed.
Recognize and address development needs, creating growth opportunities for colleagues.
Oversee and manage multiple projects and ongoing work activities, ensuring compliance with approved methodologies and cGMP documentation.
Provide technical expertise and support for laboratory and core applications, collaborating with business partners to identify and implement improvement areas.

Here Is What You Need (Minimum Requirements)

Master's Degree in Microbiology, Biotechnology, Life Sciences, or related discipline 12+ years of experience or
Proven experience in leading colleagues and managing projects
A deep understanding of Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories
Proficiency with Quality Control instruments and methodologies
Environmental Monitoring Program Management
Cleanroom Classification and Monitoring
Annex 1 Compliance
Contamination Control Strategy (CCS)
Risk Assessment Tools
Trend Analysis and Data Evaluation
Regulatory Inspection Management
CAPA and Root Cause Analysis
Laboratory Investigations
Data Integrity Requirements
GMP Documentation Practices
Regulatory Inspections Management and Handling
Area and Equipment Qualifications.

Bonus Points If You Have (Preferred Requirements)

Proficiency in Laboratory Information Management Systems like GLIMS, EQMS and Microsoft Office
Solid understanding of method qualification and testing of components and finished products
Experience in microbiological risk assessments
Strong problem-solving skills and the ability to think outside the box
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control

Skills Required

Master's Degree in Microbiology, Biotechnology, Life Sciences, or related discipline with 12+ years of experience
Proven experience in leading colleagues and managing projects
Deep understanding of Good Manufacturing Practices (cGMP) for Quality Control Laboratories
Proficiency with Quality Control instruments and methodologies
Environmental Monitoring Program Management
Cleanroom Classification and Monitoring
Annex 1 Compliance
Contamination Control Strategy (CCS)
Use of Risk Assessment Tools
Trend Analysis and Data Evaluation
Regulatory Inspection Management and Handling
CAPA and Root Cause Analysis
Laboratory Investigations
Data Integrity Requirements
GMP Documentation Practices
Area and Equipment Qualifications
Proficiency in Laboratory Information Management Systems like GLIMS, EQMS and Microsoft Office
Solid understanding of method qualification and testing of components and finished products
Experience in microbiological risk assessments
Strong problem-solving skills and ability to think outside the box
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot

What the Team is Saying

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.