Scientist, Analytical Cmc Strategy

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 is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, haematology, immunology, cardiovascular and neuroscience. Our employees work every day to transform patients’ lives through science.

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Many of the global business services, including the European Treasury Centre, Market Supply Operations and Commercial Operations have a presence in Ireland.

Ireland is also 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.

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

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

The Role

A Scientist in the analytical CMC bio group plays a supporting role for Biologic product lifecycle activities. This position focuses on providing support to commercial and late stage products with a specific focus on analytical CMC strategy, enabling regulatory filings, provide technical partnership for quality control laboratories around the world, support managing the lifecycle of specifications (methods and acceptance criteria), and authoring responses to health authority questions on commercial products.

The scientist will operate in a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions. Through a level of independence, the scientist will ensure the support of analytical methods and analytical change control across the BMS network, for third party manufacturing and our partners at outside testing labs. The scientist is responsible for data gathering, interpretation and presentation to support decision making, and product analytical strategies

Key Duties And Responsibilities

This position will be located at the Bristol-Myers Squibb site in Cruiserath, Ireland / Devens, MA. The scientist will collaborate across BMS sites with analytical development, global quality product leads, technical project teams, and regulatory leads to generate and execute the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of life cycle regulatory filings.

• Manage and coordinate analytical activities for late-stage and commercial programs.
• Participates on the implementation of effective control strategy, analytical method and specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs.
• Create and maintain effective partnerships with stakeholders from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success, as necessary.
• Serve as technical point of contact for project activities, including technical evaluations of methods and data.
• Provide technical support and guidance to QC teams during method troubleshooting / investigations / tech transfers / method validations
• Effectively support team matrix for analytical topics during all BLAs, ROW & PAS filing review and work with analytical development in supporting the responses to FUMs and PMCs.

Qualifications, Knowledge And Skills Required

• Working knowledge of analytical methodologies used for the development and commercialization of biologics.
• Demonstrates ability to analyze and interpret data to draw appropriate conclusions, identify problems/gaps, and recommend potential next steps or solutions to ensure good scientific, compliance and regulatory outcomes.
• Understanding of product characterization and strategies to establish process and product knowledge
• Proficient in the execution of some of the key analytical CMC activities (BLAs/ ROW & PAS filing preparation & review, supporting responses to FUM’s and PMC’s / method lifecycle / electronic Change Control’s).
• Proven track record in writing formal reports/documents, technical presentations, articles for publication and scientific publications or patents.
• Proficient in the preparation / protocols, methods/processes, experimental and/or authoring plans and/or templates as appropriate
• Working knowledge of the relevant principles and concepts of analytical CMC (JOS / Analytical Procedures / Method Validation etc.) and associated GMP’s.
• Possess a strong sense of time management and the ability to meet tight deadlines

Education/Experience/ Licenses/Certifications

• A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 2 of biologics experience within analytical CMC / relevant field, respectively.

Physical Demands

• This is primarily a coordination role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting. Including
• Walking-Level Surfaces
• Sitting

Work Environment

• Working with/around others
• Chemicals
• Working Alone
• Inside Work
• This is primarily a coordination role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting. Including

Travel

• This position requires approximately 25% travel.

Supervisory Responsibilities

• Ability Working within a highly matrix team (no direct supervisory responsibilities)

Why you should apply

• You will help patients in their fight against serious diseases
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.

BMSBL

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

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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.