Job Information
Bristol Myers Squibb Principle Scientist, Aseptic and Microbial Process Control Sciences in Cruiserath, Ireland
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
Bristol Myers Squibb is looking to recruit a permanent contract Principle Scientist, Aseptic and Microbial Process Control Sciences to join our team in Dublin.
This individual is accountable to establish microbial control strategies for sterile drug product manufacturing environments for the internal and external BMS drug product manufacturing network.
The aseptic processing SME will partner with the internal and external manufacturing sites to define strategies for microbial control for DP related manufacturing activities such as gowning, environmental monitoring, media fill program, and will ensure the control strategies comply with Annex 1 and FDA Guidance for Industry.
The individual will interface with the manufacturing plant to support the establishment and maintenance of critical cGMP aseptic activities, and will also support critical manufacturing investigations involving aseptic processing.
This role will closely collaborate with the MS&T Biologics Drug Product / Parenteral team as well as the Microbiology CoE Analytical group. It is expected that this role will also engage with industry forums such as PDA, BPOG, and ISPE. Direct Reports None Business Partners & Interactions
The Aseptic Processing SME influences and maintains effective collaborations across the BMS network, closely partnering with MS&T Parenteral, Quality, QC, Manufacturing, network Microbiology CoE Analytical, as well as other MS&T partner functions.
This role will interact with Health Authorities.
Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs
Key Duties and Responsibilities:
Establish microbial control strategies for sterile drug product manufacturing environments for the internal and external BMS drug product manufacturing network.
Provide oversight to site media fill programs, including elements such as required operator training and qualification, approach to coverage of all products in the media fill program, use of components, and intervention strategy. Review and approve annual media fill programs and aseptic validation master plans for internal & external sterile DP manufacturing sites.
Provide oversight to site gowning practices and environmental monitoring programs employed to ensure establishment and verification of maintenance of the aseptic processing environment
Provide oversight/input to site sterilization process qualification activities, and review and approve PQ protocols. Support Tech Transfer activities as needed.
Leadership and/or support of critical manufacturing investigations involving aseptic processing components, including root cause analysis, CAPA generation, and impact assessment. Act as the point of contact to triage microbial investigations and collaborate on resolution with microbiology SMEs across the network.
Collaborate with the Microbiology CoE Testing group, with the aim to provide process support/expertise to rapid microbiology method development and implementation in the production environment.
Support Tech Transfers and interface with the Biologics MS&T Drug Product / sterile parenteral group, site manufacturing, and product specific technical teams to align on microbial sampling strategies.
Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions. Technical SME on Quality audit team for External manufacturing sites.
Interface with industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for aseptic processing.
Technical input, authoring (when applicable), and approval of CMC documents for process validation P.3.5 sections.
Support CMC queries and resolution with Global Health Authorities, and support plant inspections.
Qualifications, Knowledge and Skills Required:
Bachelor's degree or equivalent in relevant engineering or scientific discipline with a minimum of 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.
Subject matter expert in sterile manufacturing processes and technology, and aseptic processing.
Strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of the aseptic/environmental aspects of these processes.
Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
Experience in sterile manufacturing plant(s) with interaction regarding the environmental monitoring program, gowning practices, media fill program, and/or sterilization practices and aseptic technique.
Working knowledge of microbiological testing including environmental monitoring, bioburden, bacterial endotoxin, sterility, microorganism identification, and various laboratory equipment, instrumentation, and techniques is a plus.
Strong technical writing skills.
Demonstrated strong oral and written communication skills, along with demonstrated project management experience.
Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development
Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone,
Requires approximately 20% travel
Demonstrated ability to:
Influence areas not under direct control to achieve objectives
Work strategically, manage multiple programs consistent with department objectives
Work well in a matrix environment and effectively support the decentralized manufacturing function
Build alignment with business partners including the manufacturing sites, the Micro CoE Testing group Quality stakeholders
Manage risk and make rapid decisions
Strong strategic and analytical thinking, problem solving and rapid decision making skills
Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous/matrix environment
Strong ability in negotiating and influencing without authority in complex, high impact situations
Strong presentation and communication skills both, oral and written
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, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.
BMSBL
#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.
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: R1582294
Updated: 2024-06-28 03:18:57.367 UTC
Location: Cruiserath-IE
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.