NIGHT SHIFT: Manager, Cell Therapy Manufacturing in Devens, MA at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Availability for night shift: 6pm – 6am, rotating schedule including holidays and weekends (C Shift: Wed - Sat / Th - Sat, 6pm - 6am including holidays and weekends)
Ability to work in a validated manufacturing system environment compliant with cGMP requirements
Willingness to perform shift work, including holidays and weekends

Responsibilities

Manage the creation, implementation, and compliance for all documentation, procedures, and policies
Operate within the requirements of a validated manufacturing system, plan, assign, and oversee daily operational activities associated with assigned areas of responsibility
Maintain operating and storage areas that are compliant, efficient, effective, and safe
Identify strategic and operational issues to prevent deviations and maintain a compliant environment; lead and manage the development of corrective and preventative actions, deviation responses, and investigations
Manage implementation and maintenance of appropriate training curricula
Create an environment of teamwork, open communication, and a sense of urgency; foster a culture of safety and compliance that embraces safety in the work environment and the safety of patients by compliance with company procedures, policies, and cGMP requirements
Efficiently coordinate, communicate, and provide 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
Oversee 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
Oversee operators completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
Maintain training assignments to ensure operators have the necessary technical skills and knowledge
Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification, and validation activities
Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
Hire, mentor, and develop exceptional people; conduct performance reviews and identify opportunities for career growth for manufacturing associates

Skills

Key technologies and capabilities for this role

Cell TherapyManufacturingGMPDocumentationProceduresPoliciesComplianceTeam ManagementShift Scheduling

Questions & Answers

Common questions about this position

What shifts are available for the Manager, Cell Therapy Manufacturing role?

The night shift is 6pm – 6am on a rotating schedule including holidays and weekends, and C Shift is Wed-Sat or Th-Sat, 6pm-6am including holidays and weekends.

Where is the manufacturing facility located?

The facility is located in Devens, MA.

What are the key responsibilities of this manager role?

Responsibilities include managing documentation, procedures, and policies; overseeing daily operations in validated systems; maintaining compliant areas; leading investigations and corrective actions; managing training; and fostering teamwork, safety, and compliance.

What is the company culture like at Bristol Myers Squibb?

The culture emphasizes challenging, meaningful, life-changing work with high-achieving teams, growth opportunities, balance, flexibility, teamwork, open communication, urgency, safety, and compliance.

What makes a strong candidate for this position?

Strong candidates will have experience managing manufacturing operations, ensuring cGMP compliance, leading teams in a 24/7 environment, handling deviations and investigations, and fostering safety and teamwork in cell therapy production.

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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