Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

GROUP/DIVISION SUMMARY

• The Drug Product Division
• North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

The Sr. Manager, Environmental Monitoring (EM) Lab, leads all aspects of the staff and operations of the EM Lab unit, providing strategic direction and leadership. This role establishes and implements quality policies for materials, products, and the production environment, and participates as a key member of the site's Management Team. The Sr. Manager provides technical and operational leadership for laboratory operations, technical support, and assistance to manufacturing facilities.

Key Responsibilities:

• Provide leadership by driving organizational change, empowering staff, cultivating relationships, building effective teams, fostering engagement, and supporting staff in achieving both personal career goals and organizational objectives.
• Lead all aspects of environmental microbiological testing programs for product-impacted utilities, environmental monitoring, and lead all aspects of Laboratory testing in collaboration with Quality Assurance.
• Lead environmental microbiological analysis, qualification activities for new facilities, projects, and enhanced analytical methods, as the need arises.
• Assess technical responses to regulatory agencies (e.g., FDA and EMA), advise Manufacturing/Quality Operations and Leadership on EM, microbiological matters, and sterility assurance.  Review regulatory guidelines and communicate requirements across the Steriles Business Segments.
• Negotiate Laboratory support for continuous operations, product investigations, and new project introductions.
• Develop and monitor capital equipment and operating budgets, and engage in both short-term and long-range planning for the EM Lab Department.
• Maintain an injury-free and incident-free workspace, for self and staff, while aligning with all job-related safety and training requirements.

Qualifications:

• BS/BA in Microbiology, Biology, or related scientific field required. Equivalent combinations of education, training, and relevant work experience may be considered.
• 10 years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience required.
• 7 years in a leadership role, committed to employee engagement and development required.  Team-building is a crucial skill.
• Outstanding attention to detail and organizational skills.
• Capable of excelling in a fast-paced environment, adept at multitasking. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills.
• Requires discretion and independent judgment.
• Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
• Highly effective verbal and written communication skills. Proficiency in Microsoft Suite (Word, Excel, PowerPoint).
• Superior cGMP experience and leadership required.
• Knowledge of quality control statistics, documentation and adherence to SOP’s.
• Upholds Data Integrity and cGMP standards. High attention to detail.
• Makes safety a priority
• Adaptable to changing product release priorities, flexible and structured communication skills. Ability to delegate.
• Knowledge of Microbial test methods including Bacterial Endotoxin and Sterility testing. Particulate Matter testing a plus.
• Ability to write quality technical reports and give effective oral presentations.
• Ability to effectively collaborate with others to achieve team goals and expectations.
• A genuine interest in researching and implementation of innovative approaches to analysis.