The Label Operations Manager at the S12 Cell Therapy manufacturing facility is responsible for implementing and managing the site Label Operations activities at S12 Summit West (Summit, NJ) in accordance with BMS policies, standards, procedures and Global cGMPs. Functional responsibilities include supervision of all label control activities for Cell Therapy Development and Operations (CTDO); Responsible for developing and maintaining a GMP compliant clinical and commercial label issuance and control process. The Label Operations organization is responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives. This organization supports the S12 facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
Shift Available:- Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 6 p.m. - 6:30 a.m.
Responsibilities:- The Label Operations manager will lead team to ensure Label Management and align with Global and Regional Regulatory requirements.
- Manage and motivate team members, build trust and cultivate a collaborative environment.
- Oversee team responsibilities and maintain a state of compliance.
- Work proactively to identify and address any label control compliance issues.
- Oversees, supervises, coordinates and prioritizes daily activities of the Label Operations team located at Summit, NJ S12 facility.
- Act as site lead for clinical and commercial label management related system implementation initiatives. Fully support projects within project timelines.
- Assures job objectives are met on a timely basis.
- Assures timely issuance of clinical and commercial in-process and final product labels for labeling operations.
- Coordinates and prioritizes project deliverables to support new drug product launches, new market and other quality management activities as assigned.
- Creates employee development plans, and oversight of functional area to assure adequate staffing.
- Coach and mentor subordinates in the areas of training, disciplinary action, problem solving, and professional growth.
- Provide support for activities using the electronic label issuance and control systems.
- Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site.
- Perform gap assessments to identify process deficiencies, provide reports to document detailed findings and recommend potential solutions.
- Develops and maintains quality metrics to monitor compliance.
- Collaborates with stakeholders to develop appropriate actions to resolve quality system issues.
- Responsible for developing, managing, and on-boarding requirement for new staff within label control.
- Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
- Performs supplemental investigations/projects as required by management.
Knowledge & Skills:- Must have advanced GMP, Quality, compliance and risk management knowledge.
- Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
- Provide guidance to other employees in the interpretation of compliance and technical/scientific issues across most of the job function. Develop employees and coach them to bridge knowledge gaps.
- Must have strong authorship and able to critically review reports while effectively providing input and expressing Quality Risk management principles.
- Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking.
- Must be skilled in coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
- Must possess an independent mindset and tenacity.
- Leads teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values.
- Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications.
- Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
- Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
- Routinely recognizes and resolves quality issues informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
Minimum Requirements:- Bachelor's degree required. An equivalent combination of education and relevant experience may be considered.
- Minimum 5 years of experience in pharmaceutical, biologics, cell therapy, or other cGMP-regulated manufacturing operations.
- Minimum 2 years of leadership experience with responsibility for team performance, development, and execution of manufacturing activities.
- Demonstrated experience operating in compliance with cGMP regulations, quality standards, and regulatory expectations.
- Proven ability to collaborate cross-functionally with Quality, Manufacturing, Supply Chain, and Technical Operations partners to ensure compliant and uninterrupted operations.
Working Conditions:- Work is performed in a typical office environment, with standard office equipment available and used.
- Work is generally performed seated but may require standing and walking for up to 10% of the time.
- Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
BMSCART, #LI-Onsite
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Summit West - NJ - US: $103,560 - $125,495
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
