Manufacturing Specialist Clinical Supply Operations

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Clinical Supply Operations Specialist will lead the manufacture of oral solid dosage products in a cGMP environment, ensuring strict adherence to applicable regulatory, safety, and company policies and procedures. In addition, Specialist will be responsible for leading a variety of engineering projects in support of oral solid dosage manufacturing operations.

Core Responsibilities include:

Leads the manufacture of assigned oral solid dosage product batches and completes all required documentation

Supports successful technical transfer and scale-up of new products

Participates in new technology evaluation and implementation

Establishes plans for managing workload with efficient resource utilization and within designated timeframes. Effectively adjusts plans to deal with changes and obstacles.

Troubleshoots and resolves manufacturing related issues.

Effectively supervises assigned pharmaceutical development technician(s) to ensure efficient batch execution.

Interfaces with Pharmaceutics R&D to ensure proper technical transfer and scale-up of formulae and processes into Clinical Manufacturing and out to commercial manufacturing.

Communicates effectively with management, quality unit, peers and colleagues within and outside the department for all manufacturing, quality and safety related issues.

Participates in SOP writing and review.

Participates in selected initiatives leading to the improvements on cGMP compliance, safety compliance and productivity.

Position Requirements:

Candidate should have, at a minimum, a B.E./B.S. in engineering, pharmaceutical sciences, or related discipline and 5-7 years relevant experience. Experience with pharmaceutical processes, solid dosage manufacturing and/or product or process development is essential. Detailed knowledge of pharmaceutical solid dose manufacturing equipment is required. The successful candidate must have excellent scientific, analytical and troubleshooting skills.

The successful candidate will have the ability to lead and motivate others, the capability to solve process related problems and the command of effective communication skills.

A complete understanding of regulatory and cGMP requirements and their application to clinical manufacturing are required.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com