Manufacturing Science amp Technology Packaging Senior Specialist

Profile

Job Information
Bristol Myers Squibb
Manufacturing Science & Technology Packaging Senior Specialist
in
Dublin
Ireland
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.
Bristol Myers Squibb Ireland
Bristol Myers Squibb (BMS) has been in operation in Ireland since 1964, employing over 600 people across a range of activities and business units.
The Global External Manufacturing (ExM) organization headquartered in Dublin, is responsible for the management of manufacturing and reliable supply across the Bristol-Myers Squibb global network. This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites.
In Ireland, External Manufacturing has two sites, global HQ in Dublin 15 and a distribution centre in Shannon, Co Clare.
Many of the global business services, including Commercial, the European Treasury Centre, Global Bio Lab and Global Logistics are based on the island of Ireland.Ireland is also home to Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility. This state of the art facility produces multiple therapies for the company's growing biologics portfolio and plays a central role in Bristol-Myers Squibb global manufacturing network.
ExM's strategy and robust operating model is focused on evolving and continuously improving ways of working to take External Manufacturing to the next level, leveraging data and technology in an effort to deliver product to customers and patients at optimum speed, time and cost.
The Role
BMS External Manufacturing is looking to recruit a permanent Manufacturing Science & Technology Packaging Senior Specialist
(Drug Product) for our Manufacturing Science & Technology group based in Dublin. Reporting to the Manufacturing Science & Technology Packaging Manager, the successful candidate will have the opportunity to actively be responsible for the provision of technical expertise in the area of Drug Product Packaging for products manufactured in an external manufacturing environment
Key Duties and Responsibilities:
Provide packaging technical support to External and Internal Manufacturing and Contract Manufacturing Organisations (CMOs) who manufacture and package BMS products.
Ensure robust and compliant process performance at CMOs during commercial manufacture by use of continuous process verification and Operational Excellence.
Provide ongoing technical support to ExM / CMO to ensure compliance and security of supply - metrics review, investigation close-out, change control review, APQR review, process improvement. Implement Operational Excellence initiatives as necessary.
Deviation Management, including leading technical investigations at CMOs.
Change management and technical assessments to support same.
Provides technical support in serialisation activities at CMOs.
Represents Manufacturing Science & Technology on project teams and works closely with Supplier Relationship Management and project team members in developing strategies and problem-solving efforts.
Ensure the transfer of robust packaging processes to CMOs.
Support CMO selection process - compilation of technical packages, due diligence, generate scorecard ratings.
Support site to site packaging technology transfer of products ensuring robust technical transfer within budget constraints. Generates, where required, site technology documents such as Technology Transfer plans, Validation Master plans, Process risk assessments etc.
Support operational management of CMO as per Virtual Plant governance structure.
Product robustness - participates and supports creation of packaging process robustness monitoring plan, process control strategy, and provides technical oversight of CMO sites to ensure continuous process monitoring for all products in scope.
Qualifications, Knowledge and Skills Required:
A 3rd level degree in science or a related field with at least 3 to 6 years relevant experience.
Proven record in packaging/manufacturing support activities, with potential experience in pharmaceutical packaging technology, packaging validationand/or technical transfer.
In-depth knowledge of primary and secondary packaging for Oral Solid Dosage (or Devices or Parenteral products) with knowledge of global regulatory requirements related to design and control of these processes.
Ability to close-out investigations, deviations and change management.
Knowledge of validation associated with packaging processes
Ability to use statistical software to analyse process related data to determine process capability or for troubleshooting purposes.
Experience with the technical transfer of products
Excellent verbal, written communications and presentations skills, including influencing skills, excellence at writing complex study plans and scientific reports.
Ability to work with minimal supervision, while keeping management and stakeholders appropriately informed.
Knowledge of regulations concerning cGMP, manufacturing, packaging, validation, quality systems, equipment innovations, upgrades, and instrumentation.
Ability to work on own and as part of a team to drive issues to resolution.
Experienced with use of statistical software.
Please note that there will be up to 20% travel required as part of this role.
What's important to us
Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:
Passion
: Our dedication to learning and excellence helps us to deliver exceptional results.
Innovation
: We pursue disruptive and bold solutions for patients.
Urgency
: We move together with speed and quality because patients are waiting.
Accountability
: We all own BMS' success and strive to be transparent and deliver on our commitments.
Integrity:
We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
Inclusion
: We embrace diversity and foster an environment where we can all work together at our full potential.
We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.
Why you should apply
You will help patients in their fight against serious diseases
You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 23.5 days annual leave plus 3 Company days, access to BMS Cruiserath on-site gym, life assurance and gain-sharing bonus.
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.
Company:****
Req Number:
R1525463_EN
Updated:
2020-05-29 00:00:00.000 UTC
Location:
Dublin,Ireland
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Sign Up Now - ManufacturingCrossing.com