Manufacturing Team Lead, Liso-cel CAR-T, Manufacturing Operations 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

Biotechnology, PharmaceuticalsIndustries

Requirements

Senior Associate in Manufacturing
Bachelor’s degree and 4 years of experience in cell therapy in Biopharmaceutical
Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
Knowledge of cGMP/FDA regulated industry
Basic mathematical skills
General understanding of cGMPs
Technical writing capability
Proficient in MS Office applications
Background to include an understanding of biology, chemistry, medical or clinical practices
Aseptic qualification is required

Responsibilities

Oversee set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation
Lead deviation investigations and write ups as needed
Accountable for on time closure of any assigned CAPAs within the designated shift
Aseptic technique is required for most activities: welding, connections, and transfers, at minimum
Weighs and measures in-process materials to ensure proper quantities are added/removed
Adheres to the production schedule ensuring on-time, internal production logistics
Records production data and information in a clear, concise, format according to proper GDPs
Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements
Works in a team based, cross-functional environment to complete production tasks required by shift schedule
Is a SME and qualified trainer within a designated function of manufacturing
Team Lead is responsible for the designated area within the shift
Shift supervision will be managed by the shift Supervisor, but Team Lead will act as Supervisor when needed
Maintain on time completion of training assignments and those of the associates in the designated area to ensure the necessary technical skills and process knowledge required to execute operations in a GMP compliant manner

Skills

Key technologies and capabilities for this role

cGMPSOPscleanroomCAR-Tcell therapyquality investigationsproduction deviationsGMP manufacturingblood components

Questions & Answers

Common questions about this position

What shift is available for this Manufacturing Team Lead position?

The available shift is Sunday - Wednesday (with every other Wednesday off), onsite night shift from 5 p.m. to 5:30 a.m.

What are the key responsibilities of the Manufacturing Team Lead?

Responsibilities include overseeing equipment set-up and operation for cell culture, harvest, and cryopreservation; leading deviation investigations and CAPA closures; performing aseptic techniques; adhering to production schedules; and recording data per GDPs in a cGMP cleanroom.

What skills or qualifications are required for this role?

Aseptic technique is required for most activities like welding, connections, and transfers; aseptic qualification is required; candidates must be SMEs and work effectively in a team-based environment.

What is the work environment like at Bristol Myers Squibb?

The role is performed in a controlled cGMP cleanroom environment, within a team-based, cross-functional setting according to an assigned production shift schedule, with emphasis on challenging, meaningful work alongside high-achieving teams.

What kind of candidate is BMS looking for in this Manufacturing Team Lead role?

Motivated, team-conscious individuals who can fulfill job requirements as SMEs, adhere to safety, quality, and GMP standards, and thrive in a cross-functional team environment.

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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