Senior Specialist, Sterile Drug Product, QA Manufacturing Operations

Overview

Working with Us

Bristol Myers Squibb offers challenging, meaningful, and life-changing work across departments. This environment supports growth and opportunities on a scale that fosters career development alongside high-achieving teams. The company emphasizes balance and flexibility with competitive benefits and programs to support employees' goals at work and in their personal lives.

The Role

BMS Cruiserath Biologics is seeking to recruit a Senior Specialist, QA Manufacturing Operations for Sterile Drug Product. The role reports 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 biologics portfolio and clinical pipeline, collaborating with the project team to resolve design, construction, and qualification questions and to provide quality assurance oversight for all project phases.

Additionally, the role supports readiness for 24/5 manufacturing operations, assists with the Tech Transfer program for new products, and, post start-up, contributes to QA activities related to commercial sterile drug product manufacture and release on shift in Cruiserath (this is a 24/5 shift role).

The start-up nature requires adaptability and innovation across multiple project phases and products onsite. The project scope includes construction and commissioning of the sterile drug product suite, with components such as preparation, formulation, aseptic filling and capping of liquids and lyophilized products, aseptic filling of syringes, and visual inspection capabilities, along with new and expanded clean utilities.

Key Responsibilities During Start Up

• Provide QA oversight for aseptic sterile drug product processes including formulation, filling, lyophilization, capping, and AVI.
• Collaborate with project design, CQV, and Automation/CSV teams to facilitate project design implementation and validation for Drug Product Operations.
• Prepare, review, and approve documentation (SOPs, MBRs, logbooks) to enable manufacturing start-up and complete training on time.
• Support CQV, Tech Transfer, and Operational Readiness activities including New Product Introduction, SOP development and implementation, training materials, MES/MBR design, and CQV support as required.
• Develop and execute training programs to support multiproduct manufacturing.
• Support establishment of Operational Excellence initiatives such as 5S, Standard Work, Lean Six Sigma, Kaizen, and problem solving.

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.
• Quality oversight of the inspection program.
• QA Operations review of events and investigations.
• Authoring, review, and approval of QA-related procedures and the review/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 the implementation of Manufacturing Execution System (MES) and development of batch records.
• Change control assessment and CAPA evaluation/close-out.
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
• Support external and internal audits.
• Drive and support a culture of continuous improvement and safe working practices.
• Designee for Manager, Sterile Drug Product, QA Manufacturing Operations when required.
• Support Operational Excellence initiatives such as 5S, Standard Work, Lean Six Sigma, Kaizen, and problem solving.

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 advantageous.
• Ability to work on own initiative and as part of a team; willingness to work in shifts and across a matrix to meet accelerated timelines.
• Excellent communication and presentation skills.
• Excellent time management and organizational skills with the ability to multi-task.
• Employees are expected to demonstrate the BMS biopharma behaviors to perform at their highest level.

Note: If a role intrigues you but doesn't perfectly align with your resume, you are encouraged to apply. You could be one step away from life-changing work and career developments.

Why you should apply

• You will help patients in their fight against serious diseases.
• You will be part of a company that values excellence, innovation, diversity, leadership development, and employee well-being.
• You'll receive a competitive salary and benefits, including annual bonus, pension contribution, health insurance, generous leave, and on-site facilities.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. Roles are site-essential, site-by-design, field-based, or remote-by-design, with onsite requirements defined accordingly. The company provides reasonable accommodations during recruitment and employment; inquiries can be directed to For our complete Equal Employment Opportunity statement and accessibility information, please visit our careers page.

BMS emphasizes well-being and may encourage vaccination updates as part of health and safety practices. Employment decisions consider arrest and conviction records in line with applicable laws.

If you live in or expect to work from Los Angeles County, additional information is available at

Any data related to role applications will be handled in accordance with applicable data privacy policies and regulations.

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