Senior Manager, Sterile Drug Product, Qa Technical Operations

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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.

Position Summary
BMS Cruiserath Biologics is seeking to recruit aSenior Manager, QA Technical Operationsfor Sterile Drug Product.

Reporting to the Associate Director, QA Manufacturing Operations for Sterile Drug Product, the Senior Manager will manage a QA Team supporting the start-up of a commercial drug product manufacturing facility for its biologic's commercial portfolio and clinical pipeline. During start-up this role will work in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. They will support GMP design reviews, Contamination Control Strategy, Multiproduct Manufacturing Strategy during Basis of Design and Detailed Design phases of the project and support CQV through all phases of the project.

In addition, this role will have responsibility to provide direction on readying the facility for manufacturing operations, supporting the Tech Transfer program for new products introduced into the facility.

Post start-up the successful candidate will lead the QA Technical Operations team supporting commercial & clinical sterile drug product manufacture and release activities.

The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities.

Key Responsibilities During Start Up
Build a QA Technical Operations team to support start up activities (Design, Build, CQV), GMP operational readiness and Tech Transfer Program
Responsible for hiring, coaching and development of staff Provide strategic planning and direct personnel to achieve operational goals and ensure the timely completion of tasks.
Partnership with CQV team in delivering the GMP scope of work associated with the startup of sterile drug product operations at Cruiserath.
Quality leadership for Technology Transfer QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, validation documentation and technology transfer documentation for manufacturing operations.
Collaboration with functional areas and global network for technical transfer and qualification to ensure knowledge transfer and robustness of control strategies.
Support development and execution of training programs in support of multiproduct manufacturing.
Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Key Responsibilities During Commercial Operations
Leadership of QA Technical Operations to support manufacture and release of sterile drug product at Cruiserath.
Responsible for hiring, coaching and development of staff Provide strategic planning and direct personnel to achieve operational goals and ensure the timely completion of tasks.
Provide QA technical support for commercial and clinical manufacturing operations.
Quality oversight of Product Lifecycle Management Changes (LCM's), equipment upgrades, automation upgrades, process improvements including recipe updates.
Quality oversight of Requalification's, revalidations, and periodic reviews,
Quality oversight of Major deviations, CAPA's, EV's, Change Controls and Risk Assessments
Participation in internal, corporate, and regulatory inspections
Drives and supports culture of continuous improvement initiatives and safe working practices.
Designee for Associate Director, QA Manufacturing Operations, Sterile Drug Product, when required.
Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications & Experience
The successful candidate must possess:
Bachelor/Masters in Engineering, or Science related discipline with = 10 years in Sterile Drug Product Manufacturing
Deep and demonstrated understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture.
Experience as a team leader with the ability to motivate and develop departmental staff through effective feedback and coaching.
The candidate will have proven success working well in a team environment, as well as proven leadership skills to manage a team of professionals through changing business needs.
Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture.

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, 27 days of annual leave, life assurance and on-site gym

#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.

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