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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. As a member of our team, you will get the chance to play a pivotal role to positively impact patients’ lives while developing professionally to achieve your own career goals.
Role & Responsibilities:
- Demonstrates a thorough working knowledge of the clinical supply process and the technical aspects of the CGMP’s as they relate to product packaging and labeling. Applies this knowledge to day-to-day packaging and labeling activities that produce finished packaged clinical supplies while ensuring and maintaining compliance with all quality requirements.
- Reviews the master production schedule and production orders, establishes priorities, and revises schedules according to production order specifications, established priorities and availability of workers, materials, and equipment.
- Exhibits sound judgment and strong supervisory skills by executing shop floor orders against required timelines while utilizing shop floor resources in an optimized efficient and cost-effective manner.
- Supervises union staff in all aspects of packaging and labeling of clinical supplies.
- Print clinical labels utilizing label print software and supervise union staff in the label inspection process.
- Maintains label stock inventory. Maintain employee records (attendance, vacation etc.) and conduct performance reviews of Hourly staff.
- Assures all production orders are executed in accordance with CGMP’s and departmental SOP’s. Utilizing SAP, delivers complete, error free technical documentation supporting packaging & labeling and label inspection production processes.
- Demonstrates knowledge and familiarity with a range of production equipment and can troubleshoot and resolve problems as they arise. Develops and recommends improvements to facilities, equipment, or procedures to improve quality, safety, and efficiency.
- Establish and support a work environment of continuous improvements that supports the Company’s Quality policy, Quality Systems, and the appropriate regulations for the area.
- Utilizes technical writing skills to generate procedures and guidelines.
- Utilizes prior skills to generate Master Batch Recipes Electronic Batch Record system.
- Participates on high performing teams representing global packaging organization as subject matter expert.
- Interacts and liaises with team members from CSO, Quality and Analytical & Bioanalytical Development.
- Oversees and or conducts training of new or existing employees and ensures their training is documented.
- Ensures that health and safety guidelines are followed. Maintains CGMP/Housekeeping at a high level within the department.
- Leads root cause investigations for process deviations and assigns Corrective/Preventative Actions.
- Conducts Cleaning Verification swab submission for product contact parts
Experience & Qualifications:
- Bachelor of Science or Mechanical Engineering Degree, or an equivalent amount of relevant experience may substitute
- 5+ years in a pharmaceutical industry preferably pharmaceutical manufacturing with a focus in the production of Clinical Trial Supplies.
- 3-5 years of progressive leadership or supervisory experience in the pharmaceutical industry
- Working knowledge and experience in lean /six sigma tools and concepts; 5S, Kanban, Kaizen, Green Belt Black Belt, etc.
- Prior Supervision of production staff or leadership role within a production operation with demonstrated ability in scheduling, organizing and team building is required.
- Strong working knowledge of cGMP’s and regulatory (i.e., FDA, EU, OSHA, etc.) requirements and their application within a packaging and labeling production environment. Solid record of attention to detail and strict adherence to all procedures and regulations.
- Good understanding of the pharmaceutical development process and associated scientific principles, Excellent written and communication skills. Demonstrated ability to liaise with various support groups and lead in a team environment.
- Effectively manage competing priorities, adaptable to change, demonstrated ability to accept additional responsibilities and mange tasks thought teamwork.
- Basic working knowledge of computers using MS Office, MS Outlook and business software systems commonly used in pharmaceutical industry (i.e., Electronic Batch Records).
- Prior experience in recipe building/ Master Recipe creation within MES/Electronic Batch Record systems
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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
