Specialist, Environmental Monitoring Team Lead at Bristol-Myers Squibb

Summit, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Ability to work Sunday - Thursday, onsite morning shift (4 a.m. - 12 p.m.)
Knowledge of Current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), Work Instructions (WIs), USP, EU, and other global regulatory requirements
Proficiency in environmental monitoring sampling in GMP areas, including controlled non-classified, controlled non-aseptic, and aseptic processing areas
Leadership and oversight skills for a team of samplers
Strong safety awareness and ability to perform safety Gemba walks and hazard identification
Training management skills, including assessing training levels, completing training plans, and monitoring due dates
Effective communication and collaboration with cross-functional teams (e.g., Supply Chain, QC, Manufacturing Operations, Facilities)
Problem-solving and troubleshooting abilities

Responsibilities

Ensure completion of routine and non-routine Environmental Monitoring (EM) sampling tasks in GMP areas (Summit West CAR-T Manufacturing and Warehouses) according to cGMP, SOPs, and WIs
Provide oversight for EM sample collection in controlled non-classified, non-aseptic, and aseptic areas
Take personal responsibility for safe work practices, drive team accountability, perform safety Gemba walks, identify hazards, and demonstrate safe behavior
Ensure EM sampling complies with organizational policies, procedures, state, federal, and local laws
Drive compliance with cGMP, USP, EU, and global regulatory requirements
Manage team training: drive completion, assess proficiency, monitor due dates, and allocate time for training activities
Collaborate with Supply Chain Scheduling, Abecma, Breyanzi, Media Prep, and Warehouse Ops Management for timely EM sampling
Schedule weekly routine EM sampling for the team
Serve as liaison to QC teams for EM sample testing
Communicate effectively with Manufacturing Operations, cross-functional peers, and management
Assist in troubleshooting and problem-solving with functional groups to improve efficiency and productivity
Lead EM Sampling Team to perform monitoring under static and dynamic conditions in S12/S16, S6A GMP manufacturing, and warehouse areas
Act as Point of Contact and communicate with Facilities and other functional groups

Skills

Environmental Monitoring

GMP

EM Sampling

Aseptic Processing

CAR-T Manufacturing

Cell Therapy

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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