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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.
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.
BMS Cruiserath has been awarded Biopharma Company of the Year 2019 in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022
Position Summary
The position of Principal Scientist, MS&T Material & Cryogenic Sciences serves a global network support role for drug product materials control strategies and cryogenics and cold chain science for late-stage and commercial manufacturing of biopharmaceuticals. The individual’s work scope will be focused on tech transfer and commercial manufacturing support for the Cruiserath, IRE sterile drug product (SDP) facility. This role will primarily support the new SDP facility at CRU and may also have engagement with internal and external drug substance and drug product manufacturing facilities throughout the US, Europe, and Asia.
This position will serve as a senior member in the team that works in collaboration with process development, site operations, supply chain, QC/QA, third party laboratories, and procurement functions. This individual will be accountable for material control and qualification strategies into the site while providing network material support as required. The individual will be a member of the Tech Transfer teams while leading the technical activities for new and alternate material qualification of RMs, excipients, and single-use systems (SUS). The position will also provide technical leadership to the design and validation of drug substance freeze-thaw operations and DS cold chain shipping processes and serve as the subject matter expert for related local investigation and change control.
The position will report into the Director, Material & Cryogenic Sciences, Global Capabilities & Technical Strategy, MS&T located in Devens, Massachusetts United States. This position will be located in Cruiserath, Ireland.
Key Responsibilities
- Serve as a subject matter expert for direct materials, including raw materials, excipients, consumables, and single-use-systems (SUS), used in drug product biologics manufacturing.
- Provides technical leadership for drug substance cryogenics (freeze/thaw) end-to-end control strategies.
- Accountable for execution of Material & Cryogenic Sciences book of work for CRU sterile drug product site with additional network support as required.
- Supports drug product technology transfers as a materials and cryogenic subject matter expert.
- Design, prepare, and review protocols, and experimental plans relevant to material and cryogenic workflows. Supervise external laboratory studies, as applicable. Author relevant risk assessments, technical reports, and white papers.
- Provides technical expertise, leadership, and authorship for: manufacturing investigations, change controls, new and alternate material qualifications, material specifications, and supplier change notices.
- Develops innovative, proactive approaches to the cryogenics & cold chain technologies and/or processes.
- Designs, prepares, and reviews CMC documentation as appropriate.
- Builds collaborations with third parties for design and execution of outsourced characterization or validation studies, including extractable/leachable testing of SUS.
Qualifications & Experience
Education
- Relevant degree in scientific or engineering discipline (i.e.: biochemistry, chemical engineering, materials science)
- Bachelor’s degree with minimum 10 years of relevant experience
- Masters or PhD is preferred but not required. Time spent in advanced degree programs may be considered as equivalent relevant experience.
Experience
- Understanding of materials used within biopharmaceutical processes, including but not limited to cell culture media, chemicals, excipients, consumables, filter membranes, and single-use systems is required.
- Knowledge of shipping qualification, transportation, and packaging design is required.
- Demonstration of expertise in heat transfer fundamentals is desired.
- Knowledge of protein stability is required. Knowledge of the effects of freezing and thawing on protein stability is desired.
- Knowledge of material related testing and validation practices, such as material compendial testing (i.e. USP, EP, JP), filter validation, and extractable/leachable validation is desired.
- Proven project management skills, including ability to lead multi-functional projects and work prioritization is required.
- Proficiency in writing formal reports and technical presentations is required.
- Experience with cGMP regulations, regulatory requirements, and CMC authoring for biologics processes are a plus.
Core Competencies
- Demonstrated ability to effectively navigate ambiguity and complexity,and translate into accomplishing challenging goals & objectives.
- Demonstrated aptitude for collaboration, relationship building, and influencing without authority in a matrixed environment.
- Demonstrated excellence for verbal and written communication, and presentation skills.
- Demonstrated effective organizational skills to manage a large number of projects and competing priorities in a fast-paced environment.
BMS Bio-Pharma Behaviors Required:
- Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments
- Urgency: We move together with speed and quality because patients are waiting
- Innovation: We pursue disruptive and bold solutions for patients
- Passion: Our dedication to learning and excellence helps us to deliver exceptional results
- 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
- Approximately 5-10% travel
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 assurance, 27 day 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/ 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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
