Senior Specialist, Sterile Drug Product, QA Manufacturing Operations

The Role

BMS Cruiserath Biologics is seeking to recruit a Senior Specialist, QA Manufacturing Operations for Sterile Drug Product. Reporting to the Manager, QA Manufacturing Operations for Sterile Drug Product, the Senior Specialist(s) will support the start-up of a commercial drug product manufacturing facility for its biologic's commercial portfolio and clinical pipeline. This shall be achieved by working in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. Providing quality assurance oversight for all phases of the project. In addition, this role will support readying the facility for manufacturing operations on a 24/5 basis, supporting the Tech Transfer program for new products introduced into the facility. Post start-up the successful candidate will support the execution and maintenance of the QA activities related to the commercial sterile drug product manufacture and release activities on shift in Cruiserath. This is a 24/5 shift role. The start-up nature of this project will require adaptability and innovation due to the multiple project phases and multiple products onsite. The role will be both challenging and rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid and freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities.

Key Responsibilities During Start Up

• Provide QA oversight for Aseptic Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, and AVI.
• Work with the project design, CQV, and the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.
• Prepare/Review/Approve documentation (SOPs, MBRs, Logbooks) required to enable manufacturing start-up and complete training on time.
• Support CQV / Tech Transfer / 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.
• 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.

Key Responsibilities During Commercial Operations

• QA support of manufacturing operations (commercial operations and new product introductions)
• Batch record review and on-the-floor support of manufacturing activities
• Provision of quality oversight for the inspection program
• QA Operations review of events and investigations
• Authoring, review, and approval of QA-related procedures
• Review and approval of functional area documentation
• Support the Disposition process for commercial and clinical drug product.
• Participation in GMP reviews for new facility construction and new equipment support systems
• QA support for implementation of Manufacturing Execution System (MES) and development of batch records
• Change control assessment and CAPA evaluation/CAPA close-out.
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
• Support external and internal audits.
• Drives and supports culture of continuous improvement initiatives and safe working practices.
• Designee for Manager, Sterile Drug Product, QA Manufacturing Operations, when required.
• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications, Knowledge and Skills Required

• BSc in Science or related discipline with a minimum of years' QA Operations or related experience in a Biologics or Pharmaceutical environment
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• 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.

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.

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, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. 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.

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 in completing this application, or in any part of the recruitment process, direct your inquiries to Visit 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.

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:

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