Bristol Myers Squibb Senior Downstream Manufacturing Technology Scientist/Engineer in Cruiserath, Ireland
Bristol-Myers Squibb has built a new state-of-the-art Multi-Product Cell Culture biologics manufacturing facility in Cruiserath, Dublin 15, approximately a $1 billion investment. Once commissioned, the new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network.
BMS Cruiserath Biologics is seeking to recruit a Senior Downstream Manufacturing Technology Scientist/Engineer as part of Manufacturing Sciences and Technology (MS&T). The Manufacturing Technology group provide process technical support to chromatographic, filtration, ultrafiltration/diafiltration and other downstream unit operations for the commercial manufacture of biopharmaceuticals at Cruiserath manufacturing. The successful candidate will be key contributor to a dynamic and highly technical global team. This position will build collaborations with Manufacturing, Engineering, Quality Assurance, Quality Control and Global Regulatory Sciences groups.
Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Cruiserath Multi Product Cell Culture facility.
Investigation and resolution of process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings.
Strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements.
Contributes to/Leads cross functional team (Manufacturing, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups or other process changes at BMS-MPC facility.
Assists in evaluating process performance by comparing manufacturing data to historical data from other sites.
Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Cruiserath site.
This job might be for you if:
You hold a BSc or equivalent and you have at least 4 years’ experience in downstream manufacturing technical support in the biopharmaceutical industry including experience with process validation.
You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
You have proven project management skills, including leading cross functional teams and balancing project assignments.
You have excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
You have proven problem solving ability, project management skills, including leading cross functional teams and balancing multiple project assignments.
Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level.
The BMS Behaviours are: Passion, Innovation, Accountability and Speed.
Please note: This role may require periods of extended hours or a modified work schedule and may require on-call availability.
Why should you apply:
You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
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.
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We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
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, disability or protected veteran status.