Manager, Cell Therapy Clinical Manufacturing in Devens, MA at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Experience in cell therapy manufacturing techniques, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion
Knowledge of Current Good Manufacturing Practices (cGMP’s)
Ability to operate within validated manufacturing systems
Proficiency in floor operations (trained and proficient)
Skills in hiring, mentoring, and developing people
Ability to conduct performance reviews and identify career growth opportunities

Responsibilities

Supporting the development, implementation, and compliance of manufacturing documentation, procedures, and policies
Operating within the requirements of validated manufacturing systems; planning, assigning, and overseeing daily operational activities associated with assigned areas of responsibility
Maintaining operating and storage areas that are compliant, efficient, effective, and safe
Identifying strategic and operational issues to prevent deviations and maintain a compliant environment; leading and managing the development of corrective and preventative actions, deviation responses, and investigations
Creating an environment of teamwork, open communication, and a sense of urgency; fostering a culture of safety and compliance that embraces safety in the work environment and the safety of patients by compliance with company procedures and policies, and cGMP requirements
Efficiently coordinating, communicating, and providing Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply, and other associated functions in a timely manner according to schedules and defined implementation timelines
Overseeing operators on a daily basis as they perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner
Overseeing operators as they complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
Maintaining training assignments to ensure necessary technical skills and knowledge
Assisting in the setup of manufacturing areas and equipment/fixtures and performing facility and equipment commissioning, qualification, and validation activities
Hiring, mentoring, and developing exceptional people
Conducting performance reviews and identifying opportunities for career growth for manufacturing associates

Skills

cGMP

Cell Therapy Manufacturing

Media Preparation

Cell Selection

Cell Processing

Product Fill

Manufacturing Documentation

Shift Oversight

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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