Senior Manager, Analytical Chemistry

BD (Becton, Dickinson and Company) Vernon Hills, IL
Job Description Summary

Job Description

The Senior Manager provides leadership for BD's new pharmaceutical development programs for the analytical chemistry department in accordance with all regulatory requirements. Guides, directs and reviews work done by team leaders/analytical scientist to support the development/validation of new methods and the performance of existing analytical methods. The incumbent also ensures the reliability, accuracy and cGMP compliance in support of analytical chemistry activities, supports and troubleshoots investigations into the performance of all analytical methods.

The Senior Manager's further responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. The incumbent is responsible for creating an environment that encourages technical excellence, developing and coaching technical staff to improve skills, and ensuring high quality technical work.

Responsibilities:

* Guides, directs and reviews work done by the analytical chemistry department to ensure relevancy, accuracy and cGMP compliance in support of the development of new and existing analytical methods.

* Ensures the proper technical resources and skills are in place and appropriately applied to meet and exceed development and manufacturing goals

Identifies technical, business, and interpersonal skill development needs of the members of the department and recommend appropriate training, either formal or on the job, and ensure training occurs.

* Appraises the performance, rewards, and disciplines members of the department. Is responsible for recruiting, hiring and in making salary recommendations for the members of the group.

* Plans and formulates analytical activities in support of new and current R&D efforts, including purpose of project, applications that can be utilized from findings, cost of project, equipment and human resource requirements. Plans budgets, acquires and ensures maintenance of state of the art analytical equipment.

* Coordinates analytical reports to support regulatory requirements.

* Develops and approves analytical methods and specifications for development products (raw materials, intermediates, drug substances, drug products).

* Develops, authors, reviews or otherwise facilitates the creation, execution and completion of test protocols engineering test and other technical research in support of pharmaceutical development.

* Ensures that improvements are constantly identified, prioritized and implemented in the primary areas such as process development as well as process improvements, technology transfers, and process robustness.

* Establishes, implements and maintains a system of work standards by developing guidelines and systems that ensure a consistently high level of technical work.

* Leads and facilitates laboratory investigations into aberrant, out of trend or out of specification test results.

* Participates as a Functional Management representative on new product development core teams and assists in setting goals, milestones and completion dates, evaluates and determines resources (staffing, team makeup).

* Serves as analytical chemistry SME for internal and external customers. Ensures customer satisfaction and process improvements.

* Utilizes metrics and work plan to track and continually improve process performance

Coordinates with Site EHS to ensure safe laboratory operations.

* Identifies and provides development opportunities for team members.

* Observes compliant working practices including completion of all required training, attendance at scheduled safety meetings, and performance of safe operating techniques in the labs, production areas, and office areas. Comply with all Quality, Environmental and Occupational Health and Safety policies and procedures and governmental regulations.

* Other duties as assigned by Management

Education and Experience:

* Ph.D. in Analytical Chemistry with a minimum of current or recent 5 years of management experience in pharmaceutical analytical development including broad understanding of the pharmaceutical product regulatory (CMC) approval processes (or equivalent education and experience: Masters degree with 7 years or Bachelor's degree with 10 years of experience)

* Expert experience in the design and implementation of analytical techniques. Ability to formulate and articulate cohesive strategy for method development, including regulatory aspects

* Advanced communication skills necessary to interrelate with external customers and other departments within the company structure.

* Develops, authors, reviews or otherwise facilitates the creation, execution and completion of test protocols engineering test and other technical research in support of pharmaceutical development.

* Extensive new product development experience, Pharmaceutical, Combination Product.

* Hands on in lab experience with HPLC and GC

* Ability to organize work of self and others on project with summaries that can be used by management for presentation or regulatory submission.

* Regulatory writing experience CMC.

* Experience in moving from phase 2 to 3 and into commercial manufacturing.

Primary Work LocationUSA IL - Vernon Hills

Additional Locations

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