Senior Manager Cleaning Validation at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Bachelor’s degree in engineering or related discipline required; advanced degree preferred
8+ years of experience in cleaning validation, process validation, or a related discipline

Responsibilities

Provide strategic oversight and management of the cleaning validation program, ensuring alignment with regulatory requirements and industry best practices
Develop, write, and execute cleaning validation protocols, reports, and risk assessments
Establish acceptance criteria and sampling plans for cleaning verification and validation
Delegate tasks and coordinate the execution of cleaning studies, ensuring timely and effective completion
Optimize and update cleaning validation strategies and procedures to reflect current industry standards and regulatory expectations
Perform swab and rinse sampling, cleanability, degradation and sampling recovery studies reviewing analytical results against acceptance limits
Support investigations related to cleaning failures, deviations, and non-conformances
Collaborate with Manufacturing, Quality, and Laboratory teams to ensure validated state of cleaning processes
Ensure compliance with regulatory guidelines (FDA, EMA, cGMP, ICH) and internal SOPs
Participate in audits and inspections, providing subject matter expertise in cleaning validation
Maintain up-to-date knowledge of industry best practices and regulatory expectations for cleaning validation
Lead and support projects involving new product introductions, equipment changes, or process improvements related to cleaning
Author and revise Standard Operating Procedures (SOPs) related to cleaning validation and verification activities
Regularly collaborate with Manufacturing, Quality Assurance, QC Laboratory, Engineering, and Validation teams
May interact with regulatory inspectors, third-party laboratories, consultants, and equipment/cleaning agent vendors
Determines appropriate cleaning validation approaches based on regulatory requirements, risk assessments, and product/equipment needs
Exercises judgment in troubleshooting cleaning validation failures and recommending corrective actions
Provides input into and makes decisions related to new equipment, cleaning agents, or cleaning procedures
Ensures decisions balance compliance, product safety, and operational efficiency

Skills

Cleaning Validation

cGMP

FDA

EMA

Risk Assessments

Swab Sampling

Rinse Sampling

Cleanability Studies

Degradation Studies

Sampling Recovery

Deviation Investigations

Analytical Review

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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