Specialist, Lead Manufacturing Associate, Cell Therapy - Nights at Bristol-Myers Squibb

Summit, New Jersey, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Master's Degree and 2 years of Manufacturing or Operations Experience, or Bachelor’s Degree and 4 years of Manufacturing or Operations experience, or Associate/Medical Technical degree and 8 years of Manufacturing or Operations experience, or High School diploma/GED and 10 years of Manufacturing or Operations experience
Thorough understanding of media production (if applicable), cell culture, selection/isolation, activation
Aseptic qualification required per bucket
Aseptic technique required for most activities (e.g., tube welding, connections, transfers)
Ability to work Sunday-Wednesday overnight shift (5 p.m. - 5:30 a.m., with every other Wednesday off), onsite

Responsibilities

Serve as a lead associate in the manufacture of human blood derived components per Batch Records and SOPs in a controlled, cGMP cleanroom environment
Produce blood component lots for one CAR-T bucket of operations
Cross-train in all other buckets of operations (based on availability and business need)
Provide training and guidance to manufacturing associates as required
Weigh and measure in-process materials to ensure proper quantities are added/removed
Perform and oversee process unit operations described in standard operating procedures and batch records
Complete and review documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
Assist Manager to ensure the shift performs tasks consistent with safety policies, quality systems, and GMP requirements
Serve as a qualified trainer to maintain the shift at an acceptable qualification standard
Support deviation investigations and on-time closure of deviations and CAPAs
Work with Manager to schedule daily unit operations including people, product, and material flow across multiple shifts
Ensure associates execute scheduled activities on-time, in accordance with the production schedule
Ensure batch records for production data and all information are in a clear, concise format according to proper GDPs
Help ensure the shift works effectively in a team-based, cross-functional environment to complete all production tasks required by shift schedule
Collaborate closely with Managers to ensure seamless pass down and communication of operational status
Support the quad manager for communication of production deviations, review of executed batch records, and assistance with quality investigations
Supervise the shift when the manager is not available
Other duties may be assigned, as necessary

Skills

cGMP

cleanroom

batch records

SOPs

CAR-T

cell therapy

manufacturing

quality investigations

production deviations

training

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.

Land your dream remote job 3x faster with AI

Try Jobo Free