Senior Specialist, Investigations, Cell Therapy in Devens, MA at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline plus 2-4 years’ experience in biopharmaceutical operations, or its equivalent
Experience utilizing root cause analysis/OPEX tools and identifying corrective and preventative actions preferred
Experience with Operational Excellence and Lean Manufacturing is a plus
Experience in cell therapy, biologics, or vaccine manufacturing/support desired
Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations desired
Excellent verbal/written communication skills and ability to influence at all levels
Ability to think strategically, and to translate strategy into action
Ability to prioritize and provide clear direction to team members in a highly dynamic environment

Responsibilities

Conducting and managing the resolution of root cause investigations, including impact assessments, and CAPAs as a Lead Investigator
Collaborating with many different groups/organizations as a Lead Investigator including Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control
Proactively managing the progression of investigations and CAPAs to timely and compliant closure per established KPIs
Presentation of investigation findings to key stakeholders and site senior management
Use of Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections

Skills

Key technologies and capabilities for this role

Root Cause AnalysisCAPAImpact AssessmentsLead InvestigatorProcess EngineeringCell TherapyInvestigations

Questions & Answers

Common questions about this position

What are the shifts available for this role?

Shifts available are Monday – Friday, standard working hours.

What is the salary range for this position?

This information is not specified in the job description.

What key skills and experience are required for this role?

Key skills include experience utilizing root cause analysis/OPEX tools, knowledge of cGMP’s and biopharmaceutical regulations, excellent verbal/written communication, and experience in cell therapy, biologics, or vaccine manufacturing is desired.

What is the company culture like at Bristol Myers Squibb?

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

What makes a strong candidate for this Senior Specialist role?

Strong candidates have experience as a Lead Investigator in root cause analysis, CAPAs, and impact assessments, with the ability to collaborate across Manufacturing, Quality, and Engineering teams, plus knowledge of cGMP and cell therapy manufacturing.

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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