Manager, Analytical Development Operations
Thermo Fisher Scientific

Job Info

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Work Schedule
First Shift (Days)

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

Job Description

Job Description

When you join us at Thermo Fisher Scientific, you'll be part of a hard-working, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and chances to define meaningful contributions to the world.

Location/Division Specific Information: Our Cincinnati Pharmaceutical Services Group develops and manufactures a wide range of pharmaceutical products to enable our customers to make a healthier world.

How will you make an impact?

Deliver pharmaceutical laboratory analytical development services to support needs of the business which includes Pre-clinical, Clinical, Technical Transfers and Lifecycle management support. Participates and leads internal, cross site and customer project teams. Interacts with other sites/companies on other projects as required. An authority in introduction of new technologies and approaches in support of our Customers' and business needs. Ensures that systems are in place for training, equipment validation, calibration, operation, documentation, testing and investigation of Out of Specification/unexpected results. Responsible for ensuring accurate and reliable test results and maintenance of Good Manufacturing Practices. Delivers business improvements using our PPI (planned process improvement) toolkit.

What will you do?

• Provide leadership to assigned laboratory staff by performing the following: leading organizational change; developing and empowering staff; encouraging relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting a climate where staff are motivated to do their best.
• Supervises, coaches, and develops focused teams within the Analytical Development Laboratory in Cincinnati. Provides technical direction in management, organization, laboratory design, equipment, supplies, staffing, OOS investigations, CAPA resolution, SOP input and day-to-day operation of the group while creating a team environment.
• Provides training in technology, safety and GMP requirements.
• Maintains knowledge of industry, corporate, regulatory, and compendial standards and practices related to analytical testing and pharmaceutical development.
• Participates on special project teams and task forces, as required.
• Maintains and reports various operating metrics to provide continuing evaluation of staffing needs, efficiency, cost and performance.
• Drives the business through utilization of Key Performance Indicators.

Job Scope:

Establishes operational objectives and assists in developing, modifying and implementing company policies that may have company-wide effect.

Education:

Bachelor's degree in a technical or related field. Prefer a Master of Science or PhD

Experience:

Minimum 8 years dynamic experience in the pharmaceutical industry or related industry. Demonstrates sophisticated technical proficiency. Demonstrates knowledge of Good Laboratory Practice/ GMP. Demonstrates leadership skills. Excellent organizational skills. Excellent verbal and written communication skills. Proficient with the English language.

Equivalency:

Equivalent combinations of education, training, and meaningful work experience may be considered.

Analytical method development and method validation.

Competencies:

• Awareness of quality and regulatory requirements in the pharmaceutical industry.
• Shown interpersonal and communication skills (both oral and written).
• Ability to read and interpret technical procedures and governmental regulations..

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 pound 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.
• Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

#qualitycinci

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