Senior Manager, QC Analytical Development

Regulatory Toolkit; Greenville (NC); On-site; USD 140,000 - 200,000; Full time

Job summary

Thermo Fisher Scientific Inc. is seeking a Sr. Manager, QC Analytical Development to lead the Analytical Development Laboratory unit.

You will set quality policies for materials, products and the production environment, and participate as a key member of the site Management Team. The role provides technical and operational leadership for lab operations and support to manufacturing facilities. The candidate will bring extensive cGMP pharmaceutical experience, leadership in analytics, and strong

Qualifications

• BS/BA in Chemistry or related field required.
• 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.
• Outstanding attention to detail and organizational skills.
• Excellent written and verbal communication; ability to write quality reports and present.
• Proficiency in Microsoft Suite (Word, Excel, PowerPoint).
• Knowledge of microbial test methods including endotoxin and sterility testing; particulate matter testing a plus.

Responsibilities

• Lead analytical development and method transfer activities for New Business Development projects.
• Advise on regulatory submissions and support product revisions/new introductions.
• Develop and monitor budgets for the Lab Services Department and plan long-term goals.
• Maintain safe, injury-free workspace in line with safety and training requirements.
• Drive organizational change, empower staff, build effective teams and foster engagement.

Skills

Leadership

cGMP experience

Regulatory knowledge

Analytical chemistry

Data integrity

Budget planning

Communication skills

Microsoft Office

Team building

Project management

Education

BS/BA in Chemistry or related field

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 125,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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 10,000 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, QC Analytical Development, leads all aspects of the staff and operations of the Analytical Development Laboratory 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 and technical 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 chemical Analytical Developmental and method transfer activities for New Business Development projects, and enhance analytical methods as required.
• Assess technical responses to regulatory agencies (e.g., FDA and USP), advise Manufacturing/Quality Operations Division and VP of Operations on analytical chemistry, review regulatory submissions while negotiating analytical support for product revisions and new product introductions.
• Develop and monitor capital equipment and operating budgets, and engage in both short-term and long-range planning for the Lab Services Department.
• Maintain an injury-free and incident-free workspace while aligning with all job-related safety and training requirements.

Qualifications

• BS/BA in Chemistry 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.
• 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 new approaches to analysis.

PHYSICAL REQUIREMENTS

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.