Manager, Production
Bristol Myers Squibb
Summary
The Manager of Production will be responsible for the day-to-day oversight, execution, and leadership of the drug product manufacturing team engaged in the production of radiopharmaceutical injectables at clinical and commercial scale. The Manager of Production will drive a culture of compliance, safety, and teamwork in a GMP radiopharmaceutical environment while ensuring drug products are manufactured on schedule and in accordance with all applicable quality and regulatory standards. The Manager of Production will work cross functionally to meet corporate objectives and support systems related to the commercialization of RayzeBio's programs. The Manager of Production will lead and develop a team of high performers to ensure a consistent, reliable, and timely supply of clinical and commercial drug products.
Job description
Job Responsibilities
- Provide in-plant management of production personnel and ensure GMP compliance for clinical and commercial drug product manufacturing.
- Oversee daily production schedules and batch manufacturing of radiopharmaceutical injectables to meet supply demands.
- Ensure aseptic technique and sterile manufacturing practices are followed for the production of injectable drug product to maintain product quality and patient safety.
- Manage the cleaning and sanitization of the production clean suite.
- Support the development and implementation of a robust operator qualification program.
- Draft GMP documentation including but not limited to Batch Records, SOP's, Forms, Deviations, CAPA's, Change Controls and reports.
- Support investigations and implement corrective and preventative action plans.
- Monitor and manage production department KPI's related to performance and throughput of GMP radiopharmaceutical operations.
- Ensure compliance with NRC, EH&S and US/EU GMP regulatory guidelines as required.
Education and Experience
- BS or MS in scientific related field or equivalent work experience
- At least 5 years of experience in a GMP pharmaceutical manufacturing environment, with radiopharmaceutical or sterile injectable manufacturing experience preferred.
Skills and Qualification
- Highly motivated and organized professional with strong interpersonal and communication skills.
- Proven experience building and managing teams in a GMP environment.
- Excellent professional ethics, integrity, and ability to maintain confidential information.
- Applies AI to improve team execution and decision-making
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.
Work Environment
The noise level in the work environment is usually moderate.
Requirements
- BS or MS in scientific related field or equivalent work experience
- At least 5 years of experience in a GMP pharmaceutical manufacturing environment
- Radiopharmaceutical or sterile injectable manufacturing experience preferred
- Highly motivated and organized professional with strong interpersonal and communication skills
- Proven experience building and managing teams in a GMP environment
- Excellent professional ethics, integrity, and ability to maintain confidential information
- Applies AI to improve team execution and decision-making
Benefits
- Wellbeing Support
- Retirement Benefits
- Financial Protection Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Flexible Time Off
- Paid Company Holidays
- Paid Sick Leave
- Paid Volunteer Days
- Summer Hours Flexibility
- Leaves of Absence
- Annual Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.