Manager, Senior Scientist, Quality Control Laboratory at Bristol-Myers Squibb

Aichi, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Advanced ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely
Subject matter expertise for analytical portion of new product introduction and for multiple test methods/processes across products
Ability to anticipate and perform complex troubleshooting and problem-solving independently

Responsibilities

Serve as designated point of contact for Aichi and the analytical network, interacting with global analytical science and product development teams
Manage and deploy continuous improvement and simplification initiatives in collaboration with other QC members
Own generation of protocols, reports, and other documents aligned with regulatory and corporate guidelines
Represent the department in product review boards and regulatory inspections (internal and external audits)
Author responses to regulatory requests
Lead transfers, validations, projects, CAPAs, deviations/investigations, and continuous improvement efforts
Train and mentor others on multiple QC test methods, processes, and procedures
Lead method transfer and validation of in-process, final product, and stability methods, focusing on new product introduction
Independently develop, write, and execute methods, protocols, reports, and related documents
Own and contribute to change controls
Act as delegate for laboratory management, as required
Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
Identify and escalate challenges and barriers to execution, suggest solutions, and lead remediation
Champion and foster a positive, supportive, and collaborative quality culture
Actively participate or lead in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives
Complete all required tasks compliantly and safely while modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion)
Perform other tasks as assigned

Skills

analytical chemistry

test methods

troubleshooting

problem-solving

continuous improvement

protocol generation

report writing

regulatory compliance

validations

CAPA

deviations

investigations

product transfers

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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