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Position: Manufacturing Specialist, Sterile Drug Product

Location: Cruiserath, Dublin

Position Summary

BMS Cruiserath Biologics is seeking to recruit a Senior Manufacturing Support Specialist to support the start-up of our commercial drug product manufacturing facility for its biologics commercial portfolio and clinical pipeline. 

Reporting to the Senior Manager of Operations, the Senior Manufacturing Support Specialist will play a key role in the establishing our multi-product commercial Drug Product Facility with both vial and syringe fill finish technology. This shall be achieved by providing technical leadership and input into all phases of the project, such as, CQV, Site Operational Readiness, Technical Transfer, new product introduction and commercialization activities. The successful candidate shall work to implement RFT culture with SDP during start-up.

Post start-up this role will be embedded within the Manufacturing Support team charged with supporting the Operational teams e.g., provide leadership in OE principles, lead complex investigations, support batch disposition and support new product introductions.

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.

Key Responsibilities During Start Up

Senior Manufacturing Support SME for Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, AVI and Primary Packaging

Work with the project design, CQV, & the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.

Lead/support CQV, Technical Transfer and Operational Readiness activities including but not limited to:

New Product Introduction

SOP Development and Implementation

Training Material development

MES / MBR Design

CQV support, as required.

Prepare documentation (SOPs, MBRs, Logbooks) required to enable manufacturing start-up and complete training on time.

Develop and execute training programs in support of multiproduct manufacturing.

Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Support development of the operational controls prescribed in the Contamination Control Strategy for Sterile Drug Product

Mentor and develop members of manufacturing support team.

Key Responsibilities Post Project Delivery

Manufacturing Support SME for Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, AVI and Primary Packaging

Provide SME input into cross-functional teams investigating & optimizing manufacturing processes, procedures, and documentation.

Lead operational related investigations and be the key point of contact for all other technical investigations.

Write process impact assessments to support investigation closure.

Own & drive change controls, CAPA’s, investigations, improvement projects and operational safety. Minimize human error and work with operations to remove sources of error.

Work with Drug Product Associates to generate procedures and training documentation required to enable manufacturing start-up and complete training on time.

Lead/support delivery of training to SDP team within area of responsibility

SME in supporting business systems i.e., SAP. TrackWise, Maximo etc.

Drives and supports culture of continuous improvement initiatives and safe working practices.

Lead/support external and internal audits.

Lead/support the disposition process.

Lead/support introduction of new products to manufacturing.

Lead and implement new technology solutions.

Lead/support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Designee for Sr. Manufacturing Manager, when required.

Qualifications & Experience

A Bachelors in a science, engineering, or related subject

The successful candidate must possess a Bachelor/Masters in Engineering, or Science related subject.

5+ years’ biologics manufacturing experience.

Experience in start-up desirable

Experience in new product introduction / technical transfer desirable

Expertise in sterile drug product manufacturing along with demonstrated proficiency in technical troubleshooting and resolution is essential.

Ability to support the close out of complex technical investigations.

Strong working knowledge of systems such as TrackWise, SAP.

Experience in participating in regulatory inspections such as HPRA, FDA.

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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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.

Candidate Rights

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: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1602496 : Senior Specialist, Manufacturing Support

Senior Specialist, Manufacturing Support

Benefits

Job Description