Manager, Technical Lead, Sterile Drug Product Manufacturing Operations

Manager, Technical Lead, Sterile Drug Product Manufacturing Operations page is loaded Manager, Technical Lead, Sterile Drug Product Manufacturing Operations Apply locations Cruiserath - IE time type Full time posted on Posted 24 Days Ago job requisition id R1576633

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: careers.bms.com/working-with-us .

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 Sterile Drug Product is seeking an experienced individual with aseptic manufacturing experience to provide on the floor technical leadership to our manufacturing teams within our new Sterile Drug Product (SDP) facility.

Reporting to the Senior Manager, Manufacturing Shift Lead, the SDP Technical Lead will play a key role in the establishing our multi-product commercial Drug Product Facility with both vial and syringe fill finish technology. The SDP Technical Lead will provide technical input into all phases of the SDP project, such as, CQV, Site Operational Readiness, Technical Transfer, new product introduction and commercialization activities. Post start-up this role will be embedded within the shift teams charged with delivering the manufacturing plan for the facility.

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.

This is a 24/7 shift role.

Key Responsibilities

 

• Manufacturing Technical SME for processes shall include Formulation, Filling (vial & syringe), Lyophilization, Capping, Visual Inspection & Primary Packaging
• Lead technical issue troubleshooting, resolution both during and post facility start-up.
• Provide expertise and training to SDP Manufacturing Specialists on day-to-day operations.
• Work with the cross functional departments to facilitate the implementation of the project design and validation of the SDP manufacturing facility.
• Work with SDP Manufacturing Specialists to generate procedures and training documentation required to enable manufacturing start-up and complete training on time.
• Work in conjunction with the Shift Lead to build the SDP Manufacturing teams’ technical competencies.
• Assist in the execution of commercial manufacturing processes.
• Support and lead key meetings on behalf of Manufacturing.
• Lead and implement Lean Manufacturing principles.
• Support process related investigations and QA activities.
• Lead operational readiness activities.
• Designee for Shift Lead, when required.

Qualifications & Experience

 

• A Bachelors in a science, engineering, or related subject
• Minimum 3 years’ experience in a GMP environment with a minimum of 1 years’ biopharma manufacturing experience
• Expertise in sterile drug product manufacturing along with demonstrated proficiency in technical troubleshooting and resolution is highly desirable.
• Ability to flexibly adapt to changing business needs in a start-up environment.
• Experience in lean manufacturing techniques and tools advantageous.

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, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.

#LI- Onsite

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

W e’re creatinginnovative 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.