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 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 .

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.

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

The Role

• Provide technical support and leadership to the External Manufacturing Organisation and Contract Manufacturing Organisations (CMOs).

• Ensure the transfer of robust manufacturing processes, including packaging and artwork

• Ensure robust process performance during commercial manufacture by use of continuous process verification and OPEX

Responsibilities

• Provision of ongoing technical support and oversight for a portfolio of Active Pharmaceutical Ingredients (APIs), Intermediates and Starting Materials and/or Drug Products, Packaging and artwork, ensuring compliance and security of supply - metrics review, investigation close-out, change control review, annual reviews and continuous improvement

• Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required

• Supporting CMO/vendor selection – preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of requests for information (RFIs) and requests for proposal (RFPs)

• Managing technology transfers as required

• Technical oversight and direction for process validation, as required

• Providing technical guidance in the understanding of root causes and corrective and preventive action (CAPA) identification for out of trend or out of specification results or deviations for API / intermediate / starting material manufacturing and/or DP, Packaging and Artwork processes

• Driving the use of strategies, resources and processes (OPEX, etc.) to improve processing efficiency and to ensure optimised technical support for manufacturing/packaging/artwork, technical transfer and scale-up of processes

• Provide support for change management

• Support all regulatory activities associated with changes to assigned products and new products

• Support operational management of CMO as per Supplier Relationship Management governance structure

• Represent Manufacturing Science and Technology on project teams and works closely with Quality Assurance (QA), Global Procurement, Supply Chain, Supply Relationship Manager (SRM), Product Development (PD) and project team members in developing strategies and problem-solving efforts.

• Product robustness (where required) - technical lead for creation of process robustness monitoring plan, process control strategy, and provision of technical oversight of CMO sites to ensure continuous process monitoring for all products in scope.

• Where required develop programme of experimental work to support investigations and work with PD, CMOs and external resources as appropriate to implement the programme of work.

cGMP Responsibilities/Critical Tasks

• Documentation (Transfer documentation, Appraisals, technical memos and reports, Regulatory filing, etc.)

• Deviation investigations

• Technical support for Change Control system

• Training Gap Analysis and Planning

Manage Finance

• Work with assigned CMOs to identify and agree potential process optimisations

• Reduce costs associated with existing processes

• Participate and lead on teams for cost reduction projects

Please note that there will be 20% travel required as part of this role.

Qualifications, Knowledge and Skills Required:

• The role holder will have expert knowledge in one or more of the following areas:

• API process scale-up, technology transfer and manufacturing support (change control, investigations, process optimisation)

• Drug Product - Oral Solid Dosage, Semi-solids, Liquids, Sterile/Aseptic products manufacturing

• Packaging, artwork and/or device manufacturing

• The role holder will have an understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP), filing, Environmental Health and Safety (EHS)) aspects of API and/or drug product (DP) manufacture and/or Packaging.

• Demonstrated project management and technical leadership capability.

• Demonstrated capability in the use of standard tools for root cause analysis. Ability to close-out investigations and issues at CMOs.

• Understanding of statistical process analysis and control methods. Ability to use statistical software to analyse process related data to determine process capability or for troubleshooting purposes

• Proven experience of technology transfer process

• Excellent verbal, written communications and presentations skills, to include the ability to document complex study plans and scientific reports; notifications to line management regarding critical issues related to product manufacturing and process validation where appropriate.

• Strong communication and negotiation skills as well as the ability to translate technical issues into business impact and relevant solutions.

• Ability to work on own and as part of a team and to drive issues to resolution

• For API - A graduate or post-graduate level qualification in chemistry, chemical engineering or related field. Ideally a Ph.D. qualification in Chemistry, preferably synthetic organic chemistry

• A 3rd level degree in science or a related field

• A minimum of five (5) years relevant industrial experience

• Proven record in pharmaceutical technology - pharmaceutical process scale-up, technical transfer and manufacturing/packaging/artwork support/activities

• The qualified candidate demonstrates characteristics of our BMS Values.

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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

#LI-Hybrid

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.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1581264

Updated: 2024-05-20 02:50:22.171 UTC

Location: Dublin-IRL

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.