Bristol Myers Squibb Specialist, Clinical Supply Operations in New Brunswick, New Jersey
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.
Strictly adheres to departmental, Company, and Regulatory policies, procedures, and regulations.
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.
Candidate should have, at a minimum, a B.S. in engineering, pharmaceutical sciences, or related discipline and 3 years relevant experience. The successful candidate must have excellent scientific, analytical and troubleshooting skills. Strong written, verbal and interpersonal communication skills are required to communicate effectively and contribute to multidisciplinary project teams. Additional experience with cGMP requirements and process automation systems would be beneficial.
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.