Manager, Sterile Drug Product, Qa Technical Operations

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.

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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.

The Role

BMS Cruiserath Biologics is seeking to recruit a permanentManager, Sterile Drug Product, QA Technical Operations.

Job Function:
Manager supports the start-up of a commercial drug product manufacturing facility for its biologic's commercial portfolio and clinical pipeline. This is achieved by working in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. Providing 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, the role has 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 be part of the QA Technical Operations team supporting commercial & clinical sterile drug product manufacture and release activities.

Responsibilities
Provide support to start up activities (Design, Build, CQV), GMP operational readiness and Tech Transfer Program
Partnership with CQV team in delivering the GMP scope of work associated with the startup of sterile drug product operations at Cruiserath.
Support Technology Transfer activities including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, validation documentation and technology transfer documentation for manufacturing operations.
Collaboration with functional areas 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.
Provide QA Technical Operations support to support manufacture of commercial and clinical sterile drug product.
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.
Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Required Competencies

Essential:
Leadership.
Excellent Communication skills.
Strong technical background in Sterile Drug Product Manufacture.
Understanding of GMP Principles pertaining to Biologics manufacture.
Demonstrates expert knowledge of EU, FDA, ICH and BMS Corporate cGMP policies and guidelines.
Understanding of manufacturing unit operations.
Understanding of Internal and external Regulatory requirements.

Desirable:
Strong technical writing ability.
Ability to handle multiple projects and deadlines.
Proficiency communicating and collaborating at a variety of levels in the organization.
Proven success working well in a team environment with flexibility to react to changing business needs, as well as demonstrated problem solving and project management ability.

Required Qualification(s) and Desired Experience
Bachelor/Masters in Engineering, or Science related discipline with a minimum of 5 years' experience in Sterile Drug Product Manufacturing
Understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture.
The candidate will have proven success working well in a team environment, and the ability to manage people.
Detailed knowledge of Sterile Drug Product would be a distinct advantage.
Required to work on his/her own initiative in addition to working as part of a team and must be open to shift work. Must be able to work across a team matrix to meet accelerated timelines.
Excellent communication and presentation skills are essential.
Excellent time management and organizational skills along with a proven ability to multi-task
Employees are expected to display the BMS Biopharma Behaviors, which enable them to be successful and perform at their highest level.

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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