Clinical Supplies Production Coordinator Packaging and Labeling

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.

Summary:

Strong working knowledge of cGMP’s and regulatory (i.e. FDA, EU, OSHA, etc) requirements and their application within Parenteral Product and media fill inspections. Solid record of attention to detail and strict adherence to all procedures and regulations.

Responsibilities:

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.

Schedule and coordinate trained resources to execute parenteral drug product inspections ensuring full lot s are inspected within 1 week of the DOM.

Schedule and coordinate trained resources to execute media fill inspections on day of execution.

Oversee the correct number of BME samples are taken from inspected batches supporting all required sample needs including but not limited to: Release test samples (Endotoxin, Sterility, Sterility Validation, other chemical and bioanalytical assays), Regulatory Retains, Stability Program Samples, Other Development and MS&T Samples;

SAP and Batch Record documentation of removal of samples for accountability and yield calculations

Change Control owner within the current electronic tracking system (i.e. Infinity) for visual inspection equipment or processes.

Investigation owner for deviations that occur during visual inspection, sampling, labeling, and disbursement of samples including field complaints related to parenteral products. Leads root cause investigations for process deviations and assigns Corrective/Preventative Actions.

Process owner of the visual inspection program. Responsible for maintaining the program in a current GMP compliant fashion which includes the following:

Responsible for the training, qualification and requalification of visual inspectors, including AQL inspectors. Update procedures to align with current regulatory standards and BMS Policies Be the SME that represents the operation in audits and HA inspections Create, qualify, and maintain visual inspection test kits and provide strategic rationale to support what kits cover which drug product SKUs

Demonstrates knowledge and familiarity with a range of production equipment specifically semi-automated vial inspection machines and inspection booths, and can independently troubleshoot and resolve problems as they arise. Develops and recommends improvements to facilities, equipment or procedures to improve quality, safety, and efficiency.

Assures all production orders are executed in accordance with CGMP's and departmental SOP's.

Utilizing current electronic batch record system (i.e. Delta V or SAP), delivers complete, error free technical documentation supporting parenteral inspection production processes.

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.

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.

Ensures that health and safety guidelines are followed. Maintains CGMP/Housekeeping at a high level within the department.

Bachelors of Science or a Mechanical Engineering Degree is Required

3-5 Years in a pharmaceutical industry, preferably pharmaceutical parenteral manufacturing with a focus on the parenteral inspection process. Progressive leadership or supervisory experience in the pharmaceutical industry is preferred.

Major Skills Required:

Prior Supervision 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 Parenteral Product and media fill inspections. Solid record of attention to detail and strict adherence to all procedures and regulations.

Working knowledge and experience in lean /six sigma tools and concepts; 5S, Kanban, Kaizen.

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).

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.

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