Senior Specialist, Sterile Drug Product, QA Manufacturing Operations

Senior Specialist, Sterile Drug Product, QA Manufacturing Operations

Provide QA oversight for Sterile Drug Product operations during start-up and commercial manufacturing, including readiness for 24/5 operations, tech transfer, and ongoing QA activities for release and investigations.

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 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 with the project team to provide resolution on questions during project design, construction, and qualification, providing quality assurance oversight for all phases of the project. In addition, this role will support readiness of 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 requires adaptability and innovation due to multiple project phases and products onsite. 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 & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities, and 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 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 a 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 2 - 3+ 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
• Ability to work on own initiative and as part of a team; must be open to shift work and able to work across a team matrix to meet accelerated timelines
• Excellent communication and presentation skills
• Excellent time management and organizational skills with a proven ability to multi-task
• Employees are expected to display BMS Biopharma Behaviors

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 limited to, 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 and employment details follow local policy. BMS is committed to equal opportunity employment and to providing reasonable accommodations on request. Vaccination guidelines may apply where legally required.

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