Sr. Specialist, External Manufacturing Quality Assurance at Bristol-Myers Squibb

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

BS/MS degree in science related field (including biology, biochemistry, chemistry)

Responsibilities

Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations
Develops and implements policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution in accordance with organizational strategy and business realities
Ensures approved quality systems are established and maintained to RayzeBio’s quality standards and regulatory requirements
Partner closely with CMOs and RayzeBio’s leadership team to ensure consistent and collaborative messaging to external manufacturing partners
Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners. Provide communication, support, and guidance to manufacturing partners and within the QA team. Effectively communicate issues, risks and proposed solutions within the organization
Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to Externally Manufactured product
Identify and report discrepancies from required work practices or procedures to management
Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate
Participate as requested in the response team for audits and inspections by health authorities
Provide quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements, regulatory standards, and RayzeBio procedures (clinical, commercial, and Standard of Care products per cGMP)
Provide Quality support and oversight for CMO operations and disposition activities including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Lot Disposition
Interact with the Qualified Person (QP) as needed to facilitate release of EU doses

Skills

Key technologies and capabilities for this role

cGMPQuality AssuranceCMO OversightDeviation ReviewBatch DispositionRegulatory ComplianceRadiopharmaceuticalsManufacturing Quality

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

Is this a remote position or does it require being in the office?

This information is not specified in the job description.

What are the key responsibilities for this role?

The role involves quality oversight of CMO operations for radiopharmaceutical products, supporting disposition processes including review of deviations, CAPAs, change controls, batch records, and lot disposition, and interacting with the Qualified Person for EU dose release.

What is the company culture like at Bristol Myers Squibb and RayzeBio?

The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and emphasis on balance and flexibility.

What makes a strong candidate for this Senior Specialist role?

Strong candidates will have expertise in quality assurance for CMO operations, knowledge of cGMP, experience with deviations, CAPAs, change controls, batch records, lot disposition, and ability to partner with CMOs and leadership.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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