Associate Director, Pharma MS&T Commercial Drug Product

3 weeks ago

Dublin, Dublin City, Ireland Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.

Ireland is home to External manufacturing's global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO's) and ensuring reliable supply of product to patients 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 Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.

The Role

BMS External Manufacturing is looking to recruit a permanent Associate Director, Pharma MS&T Commercial Drug Product.

Key Duties and Responsibilities:

Provide technical leadership within Manufacturing Science & Technology (MS&T) in External Manufacturing Organisation (ExM) and to Contract Manufacturing Organisations (CMOs). Act as a recognized subject matter expert in oral solid dosage drug product manufacturing. Act as a mentor, coach/trainer or consultant in the External Manufacturing Organisation and for Global Manufacturing Supply (GMS) and Research and Development (R&D), when required. Act as the Technical Lead and/or project lead in tech transfer projects. Ensures a high level of current technical knowledge is maintained within the ExM MS&T group Provide leadership support and technical consultation to MS&T Director. Lead teams of MS&T scientists where required. Maintain Technical Leadership/ Subject Matter Expertise in manufacturing sciences (formulation science and oral solid dosage Processing) Proactively ensures that an appropriate technical knowledge level is maintained within the MS&T group, through lessons learned exercises and targeted knowledge acquisition and sharing Responsible to ensure a consistent level of robust investigation capability, root cause analysis and identification of resolution mechanisms Accountable for leading significant projects in technology transfer and process robustness improvement. Creates policies, directives and procedures to ensure maintenance of technical best practice and regulatory compliance Supports ongoing operational management of Third Parties/CMO within Virtual Plant Teams Represent Pharma MS&T in internal and external teams and committees such as development-to-launch, Technical (Technical Product Team) TPT, (Global Operations) GO teams, etc. Provide ongoing technical support to ExM / CMO to ensure compliance and security of supply – including metrics review, investigation close-out, change control review, Annual Product Quality Report (APQR) review, process improvement. Implement / Operational Expenditure (OPEX) initiatives as necessary. Product robustness – technical lead for creation of process robustness monitoring plan, process control strategy, and provides technical oversight of (Third Party Manufacturing) TPM sites to ensure continuous process monitoring for all products in scope. Assists in the development of MS&T strategy Supervise work of MS&T scientists, when required

Qualifications, Knowledge and Skills Required:

Subject Matter expert level knowledge of oral solid dosage products formulation, manufacturing In-depth knowledge of global regulatory requirements related to design and control, including validation/qualification of pharmaceutical manufacturing/ packaging processes, including equipment qualification Experienced with use of statistical software to Design of Experiments (DOEs) and analyse process related data. Proficient in the technology transfer of products to CMOs within budget and according to project timeline. Demonstrated ability to manage one or more tech transfer projects with minimal supervision. Demonstrated excellence in the tools and work processes associated with operational excellence and problem solving. Excellent verbal, written communications and presentations skills, including excellence at writing complex study plans and scientific reports. Confident ability to create and nurture key internal and external relationships across different functions within BMS and in the external manufacturing partner network. A 3rd level degree in science or a related field with a minimum of 10 years relevant experience . Proven record of achievement in technical and project leadership. Experience of the use of statistical software. Ability to interact at all levels of the organisation with proven influencing ability Acknowledged technical leadership amongst peers in the organisation

Why you should apply

You will help patients in their fight against serious diseases You will be part of a 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, 27 days of annual leave, access to BMS Cruiserath on-site gym, life assurance and gain-sharing bonus.

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