Senior Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology)

Job title:

Senior Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology)

Company

Bristol-Myers Squibb

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 IrelandBristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business unitsLocated 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 and 2021.For more information about Bristol Myers Squibb, visit us at BMS.com/ieThe RoleBMS Cruiserath Biologics is seeking to recruit on a fixed-term contract (maternity cover for 12 months) Senior Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology), reporting to Associate Director, Sterile Drug Product MS&T.Position SummaryThis Sterile Drug Product Technical Transfer Senior Scientist (Manufacturing, Science & Technology) supports key technology transfer activities in the Parenteral MS&T group. This position supports the technical interface between the sending and receiving sites to ensure design and transfer of robust manufacturing processes for new products and key lifecycle parenteral products. This role ensures processes are transferred and validated per applicable cGMPs, BMS procedures, and that processes are defined consistent with regulatory filings. The role will also be responsible for scale up activities, authoring key technical documents, process performance qualification, and drafting CMC submissions.This position will report into the Tech Transfer Lead within Biologics Manufacturing Science & Technology, Cruiserath Biologics. The successful candidate will be part of a cross functional technical team to ensure project delivery across the technical transfer project.Key Duties and Responsibilities

• Perform a technical expert role which will support the technology transfer of biologics drug products for the Cruiserath Sterile Drug Product facility.
• Perform a technical expert role in various areas of aseptic manufacturing of parenteral dosage including equipment preparation, formulation, aseptic vial and syringe filling, and automated visual inspection.
• Support parenteral technology transfer projects for key lifecycle biologic parenteral products, including the establishment of the process/parameters for each unit operation of the process.
• Execute development studies, product characterisation studies, process optimisation and troubleshooting of manufacturing processes of parenteral dosage forms.
• Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
• Prepare and review technology transfer plans, development study protocols, validation protocols, technical reports, and operational procedures, as appropriate.
• Prepare technical assessments on new materials and components. Prepare protocols and execute qualification of new materials and components.
• Work cross functionally to lead any validation studies, process performance qualification and new product introductions in the SDP manufacturing facility.
• Contribute to technical decision-making that impacts project deliverables and schedule for facility start up.
• Develop and maintain effective working relationships with other division groups in support of technology transfer, validation, and process support activities.
• Responsible to co-author and review key CMC section of regulatory filings.
• Maintain compliance to industry standards and implement best practices across knowledge transfer, technology transfer, and process validation.

Qualifications, Knowledge & Experience

• Experienced in parenteral operations including aseptic processing, sterilisation, sterile filtration, isolator technology, lyophilisation, and fill-finish operations.
• Strong knowledge of global regulatory requirements, especially EU GMP guidelines and FDA CFR guidelines, related to the design and control of these processes.
• Experienced with the execution of technology transfer and scale up projects for commercial drug product manufacturing processes.
• Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.
• Proven ability to lead complex investigations relating to equipment, processes and systems associated with aseptic manufacture of drug products.
• Experienced in sourcing and qualification of vial and/or syringe container closure and drug delivery systems.
• Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture.
• Excellent organisational skills, data science knowledge, and statistical skills are required.
• Problem solving and project management ability, as well as lean manufacturing experience is desired.

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.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, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

BMSBL#LI-HybridIf 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 ProtocolBMS 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 . Visit 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:Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Expected salary

Location

Ireland

Job date

Sun, 24 Nov 2024 07:34:26 GMT

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