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Principle Scientist, Aseptic and Microbial Process Control Sciences
Client:
Bristol Myers Squibb
Location:
Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
dbf636791964
Job Views:
85
Posted:
21.01.2025
Expiry Date:
07.03.2025
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 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.
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.
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.
Key Duties and Responsibilities:
* Establish microbial control strategies for sterile drug product manufacturing environments.
* Provide oversight to site media fill programs, including operator training and qualification.
* Provide oversight to site gowning practices and environmental monitoring programs.
* Provide oversight/input to site sterilization process qualification activities.
* Support critical manufacturing investigations involving aseptic processing components.
* Collaborate with the Microbiology CoE Testing group for rapid microbiology method development.
* Support Tech Transfers and interface with the Biologics MS&T Drug Product / sterile parenteral group.
* Participation in site assessments/vendor selection for CMOs/vendor.
* Interface with industry consortiums to maintain a view of current trends and best practices.
* Provide technical input and approval of CMC documents for process validation.
* Support CMC queries and resolution with Global Health Authorities.
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.
* Subject matter expert in sterile manufacturing processes and technology.
* Strong knowledge of global regulatory requirements.
* Knowledge of SOPs, cGMPs and GLPs.
* Experience in sterile manufacturing plants.
* Working knowledge of microbiological testing is a plus.
* Strong technical writing skills.
* Demonstrated strong oral and written communication skills.
* Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts.
* Requires approximately 20% travel.
* Demonstrated ability to influence areas not under direct control to achieve objectives.
* Strong strategic and analytical thinking, problem solving and rapid decision making skills.
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.
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