Bristol-Myers Squibb Company
Jersey City, NJ, United States
Engineering, Sciences, Cad
Mar 20, 2020
Jul 03, 2020
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.
PURPOSE AND SCOPE OF POSITION
This position is responsible for management of packaging projects including but not limited to the creation of engineering documents (drawings, specifications, protocols, reports, change controls, etc), execution of packaging test plans, execution of shipping validation studies, development of labeling and artwork solution, and management of external packaging vendors and internal stakeholders to support the production of personalized cell therapy products for both global clinical trials and commercial supply. Candidate is expected work on cross functional teams, exhibit ownership and deliver on-time results while optimizing quality and performance. This is a unique opportunity to work on packaging of novel cell therapy products within Global Manufacturing Science and Technology Organization.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Demonstrated skills in project management with the ability to independently plan, prioritize, schedule and coordinate multiple projects simultaneously
Excellent analytical, critical-thinking, and creative problem-solving skills, with ability to analyze information / situations efficiently. Strong skills in technical writing.
Attention to details with focus on quality.
Flexible in adapting to changing project priorities and work assignments.
Ability to work under pressure with demanding deadlines, and Manage risk and make rapid decisions
Drive strong collaboration within the plant and across the network and Promote a mindset of continuous improvement, problem solving, and prevention
Experience in a cGMP environment with track record of managing multiple quality records.
Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals including primary container analysis.
Thorough understanding of regulations, familiarity of regulatory environment and industry trends for design of primary/secondary container, labeling.
DUTIES AND RESPONSIBILITIES
Lead on development of packaging and shipping validation test plans, generating test protocols, executing testing internally and with external test labs, and generating test reports.
Collaborates with development team to ensure all novel primary and secondary packaging materials including labeling components meet technical, legal, and regulatory requirements.
Liaisons with manufacturing and operational sites to support packaging and shipping related deviation investigations/CAPAs, impact assessments, and change controls.
Creates and maintains packaging specifications and artworks for primary packaging, secondary packaging, and shipping materials and components.
Stays current with industry/regulatory standards and trends, drives continuous-improvement and optimization projects within the packaging engineering and larger GMSAT teams.
Involvement (Either leading or supporting) with all activities related to the functional packaging, labeling, and shipping requirements for the incoming raw materials and final drug product.
Leads activities to determine requirements for packaging/labeling/shipping materials, obtains prototypes, drafts protocols and reports for feasibility, qualification, and validation, to ensure packaging/labeling materials and systems appropriately protect the product and patient including: stability, distribution qualifications, package strength/integrity, biocompatibility, leachable/extractables, label adherence/legibility, etc.
Preparation of Packaging documentation for Regulatory submissions and maintain permanent inspection readiness and actively support regulatory inspections.
Providing guidance to the manufacturing/packaging process, and product clinical and commercial labeling activities at the manufacturing site.
Initiates and performs packaging studies to contain package material cost or effect package changes that result in greater efficiency, less waste, longer stability, etc. Expresses desire to make high quality decisions based on sound analysis and review of data and alternatives.
Oversee technical challenges for material, label & packaging selection. Identify ‘best practices’ for label printing.
EDUCATION AND EXPERIENCE
Bachelor’s Degree in Engineering required (Packaging Science or Package Engineering is preferred)
8 or more years of Package Engineering experience in a healthcare related industry (Biologics, Medical Device, Pharmaceutical preferred)
Experience working with cold-chain shipper Design/Qualification required (LN2/cryogenic technologies preferred) ASTM and ISTA packaging test standards and methods.
Experience working with external packaging, test lab vendors and leading cross-functional teams is required.
Experience with AutoCAD/ArtiosCAD, Adobe Illustrator and Photoshop.
Experience with cGMP’s, cGDP’s, and Data Integrity.
Experience with Label and artwork design, Thermal Transfer Printers, Labeling Software/Systems, Label Testing, COI/COC preferred
Strong verbal/written communication skills and ability to influence at all levels is required
Ability to think strategically and to translate strategy into actions
Ability to prioritize and provide clear direction to team members in a highly dynamic environment
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
DEFINITIONS AND ABBREVIATIONS (As Applicable)
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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.
Bristol-Myers Squibb Company
Website : http://www.bms.com