Associate Director of Validation at Bristol-Myers Squibb

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, RadiopharmaceuticalsIndustries

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related discipline
Preferred: Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent)
Minimum 8 years' experience in validation within pharmaceutical/radiopharmaceutical manufacturing, including large-scale capital project support (>$10M)
Extensive experience in validation within radiopharmaceutical or pharmaceutical manufacturing
Strong technical background in process and facility qualification

Responsibilities

Lead, plan, and execute the validation strategy for manufacturing facilities, utilities, equipment, process technologies, and computerized systems
Develop and oversee validation master plans, protocols (IQ/OQ/PQ), and reports for new or expanded manufacturing capabilities (facility, equipment, utilities, and processes)
Direct and coordinate multidisciplinary validation teams, including hiring, mentoring, and professional development of validation personnel
Collaborate closely with site leadership, engineers, QA/Quality, and external vendors and contractors to ensure timely and compliant validation delivery for expansion, renovation, and site build projects
Ensure adherence to budget, schedule, and quality standards within validation scope across all site projects
Review and approve technical documentation, validation protocols, risk assessments, and qualification deliverables
Manage and resolve deviations, CAPAs, and change controls related to validation and qualification activities
Support regulatory inspections, audits, and responses by ensuring site validation compliance and documentation integrity
Lead validation efforts to support site/facility strategic initiatives, new technology integration, and global harmonization as needed
Drive continuous improvement of validation processes for enhanced site reliability and regulatory compliance
Lead and mentor the deviation investigations team for the site
Uphold all safety standards; ensure safe handling of radioactive materials and hazardous equipment throughout validation activities

Skills

Key technologies and capabilities for this role

ValidationcGMPFDAUSPManufacturingUtilitiesEquipmentProcessesComputerized SystemsRadiopharmaceuticalsPharmaceutical ProductionCross-functional Team Management

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 on-site work?

This information is not specified in the job description.

What salary or compensation is offered for the Associate Director of Validation role?

This information is not specified in the job description.

What key skills and experience are required for this role?

The role requires extensive experience in validation within radiopharmaceutical or pharmaceutical manufacturing, a strong technical background in process and facility qualification, and expertise in leading validation strategies including IQ/OQ/PQ protocols.

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

The culture emphasizes challenging, meaningful, and life-changing work alongside high-achieving teams, with opportunities for growth, balance, and flexibility in a dynamic biotechnology environment focused on cancer treatments.

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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