Company

Bristol-Myers SquibbSee more

addressAddressFingal
type Form of workFull Time
salary SalaryCompetitive
CategoryEngineering

Job description

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: .

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.

The Role

As a Principal Scientist for MS&T Cryogenics & Materials Sciences, you'll play a key role in supporting global biologics network strategies for materials control and drug substance storage and cold chain. You'll work closely with internal and external manufacturing facilities across the US, Europe, and Asia, providing technical leadership for the design and validation of drug substance freeze-thaw operations, cold chain shipping processes, and single-use systems and raw materials used during manufacturing.

You'll collaborate with process development, site operations, supply chain, QC/QA, third-party laboratories, and procurement functions, serving as a senior member of the team. Reporting to the Associate Director, Cryogenics & Cold Chain Sciences, Global Capabilities & Technical Strategy, MS&T in Devens, Massachusetts, you'll eventually transition fully to Cryogenics & Cold Chain scope as new technology transfer projects are initiated in the space. This exciting opportunity is based in Cruiserath, Ireland.

Key Responsibilities:

  • Provides technical leadership for materials and drug substance cryogenics end-to-end control strategies.

  • Supports drug substance and drug product technology transfers as a subject matter expert.

  • Develops innovative, proactive approaches to the Cryogenics & cold chain technologies and/or processes.

  • Leads cross-functional execution of process improvement projects.

  • Designs, prepares, and reviews CMC documentation as appropriate.

  • Provides technical expertise, leadership, and authorship for: manufacturing investigations, change controls, material qualifications, and risk assessments.

  • Builds collaborations with third parties for design and execution of outsourced studies.

  • Designs, prepares, and review protocols and reports relevant to cryogenics and materials workflows.

Qualifications:

  • Relevant degree in scientific or engineering discipline (ie: biochemistry, chemical engineering, material 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 process, including but not limited to cell culture media, chemicals, excipients, consumables, 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.

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.

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 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 . Visit 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.

Refer code: 2505724. Bristol-Myers Squibb - The previous day - 2024-01-13 09:57

Bristol-Myers Squibb

Fingal

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