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 Senior Drug Product Associate will play a key role in establishing our multi‑product commercial Drug Product Facility with both vial and syringe fill finish technology. The Senior Drug Product Associate will provide input and support 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.
The position will commence on a day schedule, with a planned transition to shift work in the future.
Key Responsibilities
Manufacturing SME in one or more processes that include Formulation, Filling (vial & syringe), Lyophilization, Capping, Visual Inspection & Primary Packaging
Lead technical issue troubleshooting, resolution both during and post facility start‑up.
Work with the cross‑functional departments to facilitate the implementation of the project design and validation of the SDP manufacturing facility.
Support all phases of Commissioning / Qualification and Validation during Start‑up phase of state‑of‑the‑art Drug Product Facility
Support all Capital / Tech Transfer / Operational Readiness activities including but not limited to:
Vendor site Factory Acceptance Tests
MES / MBR Design
SOP Development and Implementation
Training Material development
Room layouts and Ways of Working
Support delivery of training to SDP team on day‑to‑day operations within area of responsibility
Work in conjunction with the Shift Lead/Technical Lead to build the SDP Manufacturing teams technical competencies across a given area.
Lead the Right First‑Time execution of commercial manufacturing processes within areas of responsibility.
Support key meetings on behalf of Manufacturing.
Support and Lead key Operational Excellence initiatives (5S / Std Work / LSW / Kaizen / Problem Solving etc.)
Support Operational related investigations and be the key point of contact for all other functional investigations.
SME in use of process automation systems (i.e., Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP, Trackwise, Maximo etc.).
Co‑ordinating delivery review of batch and exception reports for manufacturing lots in conjunction with Quality Assurance representative for area of responsibility
Drives and supports culture of continuous improvement initiatives and safe working practices.
Designee for Tech Lead, when required.
Support any other business deliverables as needed.
Qualifications & Experience
A Bachelors in a science, engineering, or related subject is desirable.
Minimum 3 years’ experience in a GMP environment with a minimum of 1 year’s 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, 27 days of annual leave, life assurance and on‑site gym.
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.
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.
R1602499 : Senior Drug Product Associate, Sterile Drug Product
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