Senior Specialist, QC Instrument Management 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

Understanding and application of domestic and international GMP requirements, as well as BMS internal GMP requirements
Understanding and application of the Japanese Pharmacopoeia
Ability to gather and apply industry best practices
Skills to create technical documents (e.g., validation documents, operating procedures)
Problem-solving ability and mentality, technical expertise, and logical thinking
Effective communication skills with colleagues or stakeholders regarding task completion and needs
Ability to work in a fast-paced team environment, manage multiple task deadlines, and prioritize
English reading, writing, and speaking skills
Bachelor's degree in a related field with 5+ years of experience, or Master's with 3+ years, or PhD with 1+ year, or Bachelor's in non-related field with 9+ years, or equivalent education and experience combination

Responsibilities

Conduct testing of intermediate products and raw materials (routine tests, environmental monitoring, stability testing, etc.) using complex and non-complex methods, independently based on own judgment with upper-level advice as SME
Create, review, and revise technical documents such as test methods and SOPs as needed
Lead lifecycle management of lab instruments from introduction to disposal, including: leading introduction plans and creating requirement specifications; leading change management for introduction/change/disposal; leading validation plans/reports and execution; leading creation of instrument operation procedures with deep understanding of principles; establishing and managing periodic calibration/maintenance systems, scheduling, and report creation; leading user and data management; handling instrument failures appropriately; ensuring external vendor calibration/maintenance complies with Japanese GMP and BMS requirements; leading use and maintenance of IT systems like Maximo; communicating nearly independently with other BMS sites as needed
Execute other assigned tasks
Mentor and train junior positions, provide input to scheduling and planning, and act as deputy for lab management as needed
Lead projects within the team; contribute to or lead complex projects as needed
Actively participate in operational excellence (OpEx) and continuous improvement (CI) activities within and outside the team
Actively participate in cross-functional activities outside the team
Consistently embody BMS values, complete all tasks in compliance with compliance and safety standards

Skills

Key technologies and capabilities for this role

QC Instrument ManagementEquipment Lifecycle ManagementValidationCalibrationChange ManagementSOP DevelopmentGMP ComplianceMaximoProject ManagementTesting MethodsEnvironmental MonitoringStability Testing

Questions & Answers

Common questions about this position

What are the required qualifications and experience for this role?

Candidates need a bachelor's degree with 5+ years of relevant experience, a master's with 3+ years, a PhD with 1+ year, or a non-related bachelor's with 9+ years, or equivalent education and experience.

What key skills are required for the Senior Specialist, QC Instrument Management position?

Required skills include understanding and applying domestic/international GMP and BMS GMP requirements, Japanese Pharmacopoeia knowledge, creating technical documents, problem-solving with logical thinking, effective communication, multitasking in a fast-paced environment, and English proficiency.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position, or what is the work location policy?

This information is not specified in the job description.

What does Bristol Myers Squibb say about applying if my experience doesn't perfectly match?

BMS encourages candidates to apply even if the role doesn't perfectly align with their resume, as they could be a great fit.

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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