Associate Director, Analytical Sciences Lead - Durham, United States - Merck

Description

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.

A unique opportunity has arisen for an Associate Director, Analytical Science Lead, reporting to Global Quality Large Molecule Analytical Science. This position will be responsible for leading the Analytical Sciences teams at our three of our sites. This critical role will provide leadership at global and site level in the development of plans for new analytical technology introduction into testing laboratories, ensuring world class supply for our patients around the world. The position will oversee the transfer, validation, and lifecycle management of analytical methods. In addition, the role will provide training and investigations leadership to the Quality Control function.

Job Functions:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Lead a high performing team of experts in analytical sciences
• Provide technical oversight for the introduction of new methods and analytical equipment
• Strong Analytical Technology Transfer knowledge & complex problem-solving skills
• In-depth analytical science, method development & method validation expertise
• Ability to translate equipment & technical requirements from development to the quality testing environment
• Knowledge of equipment qualification and lifecycle management
• Coach & develop AS scientists in new product introduction and complex investigations
• Working collaboratively across disciplines to create long range analytical technology plans with Global Development & Commercialization Teams
• Represent the function as required at Global Product Forums & Partner with Global Centers of Excellence

Minimum Education Requirement and Experience:

• Bachelor's Degree in Analytical Science, Science, or other related discipline with eight (8) years' experience in Biologics Method Establishment, Technology Transfer & Method Development, and Validation OR
• Master's degree in Analytical Science, Science, or other related discipline with six (6) years' experience in Biologics Method Establishment, Technology Transfer & Method Development, and Validation

Required Experience and Skills:

• Experience in direct people management and ability to coach a talented team of technical professionals
• Strong Organizational Skills – ability to manage multiple priorities and multiple stakeholders
• Ability to lead and work collaboratively across a global organization
• Flexible, self-motivated with a passion for innovation
• Experience with Analytical Method Validation/Transfer and relevant guidelines, such as USP 1220, ICH Q2/Q14

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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Employee Status:

Relocation:

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Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/18/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R298939