Manager

Description:

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.