Manager, Clinical Manufacturing, Cell Therapy 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 leading and managing teams, including hiring, mentoring, developing people, conducting performance reviews, and identifying career growth opportunities
Skilled in floor operations and trained/proficient for them
Ability to create an environment of teamwork, open communication, sense of urgency, safety, and compliance

Responsibilities

Supporting the development, implementation, and compliance of manufacturing documentation, procedures, and policies
Operating within validated manufacturing systems; planning, assigning, and overseeing daily operational activities in assigned areas
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 development of corrective and preventative actions, deviation responses, and investigations
Creating an environment of teamwork, open communication, sense of urgency; fostering a culture of safety and compliance embracing company procedures, 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 functions per schedules and timelines
Overseeing operators daily as they perform unit operations and support operations per SOPs and batch records in a safe, GMP-compliant manner; complete required documentation; maintain training assignments for technical skills and knowledge
Assisting in setup of manufacturing areas and equipment/fixtures; performing facility and equipment commissioning, qualification, and validation activities
Hiring, mentoring, and developing exceptional people; conducting performance reviews and identifying career growth opportunities for manufacturing associates
Providing oversight of shifts covering up to 24/7 cell therapy manufacturing unit operations (e.g., media preparation, cell selection, cell processing, product fill)

Skills

Key technologies and capabilities for this role

cGMPCell Therapy ManufacturingMedia PreparationCell SelectionCell ProcessingProduct FillManufacturing DocumentationClinical Operations

Questions & Answers

Common questions about this position

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.

Is this a remote position or does it require on-site work?

The role is based in Devens, MA and involves on-site oversight of 24/7 manufacturing shifts, indicating it is not remote.

What are the main responsibilities of this role?

The manager supports clinical operations by developing manufacturing documentation, overseeing daily activities in validated systems, maintaining compliant areas, leading investigations, and fostering teamwork and safety.

What is the company culture like at Bristol Myers Squibb?

The culture emphasizes challenging and meaningful work, teamwork, open communication, a sense of urgency, safety, compliance, and opportunities for growth alongside high-achieving teams.

What shifts are available for this position?

Shifts are to be determined (TBD) and cover up to 24/7 operations for 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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