Senior Manager, CNC

Job Summary:

We are seeking a highly skilled Senior Manager, CNC & MAL Operations to join our team. The successful candidate will be responsible for executing process, assuring adherence, and optimizing execution of personnel, flow, and waste movement for production areas supporting MSS and Value Stream (VS) operations within CAR T clinical and commercial operations in multiple cGMP cleanroom suites.

Key Responsibilities:

• Execute and control optimized flow for VS/MSS production processes, materials, personnel, and waste to assure individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs, and applicable policies, regulations, and certifications.
• Ensure execution of cGMP, cleanroom requirements, and flow application to enable timely, compliant, and efficient completion of production tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Take personal responsibility to work safely and drive accountability and process for team members to do the same.
• Perform regular safety Gemba walks, identify hazards associated with team's work, and demonstrate safe behavior when operating and maintaining equipment to prevent injuries or incidents.
• Accountable for the Process Documentation produced by teams and effective documentation for business processes and ensure that all documentation produced by the team follows the ALCOA+ principles.
• Understand Cell Therapy production steps and sequence for each Unit Operation, role model good execution and behaviors for team members.
• Actively define work priorities and adjust as necessary to align with site and or functional priorities, establishes the team goals and monitor, measure, and assess the performance/completion of the team production activities and goals.
• Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans.
• Drive completion, adherence to training requirements, and assess appropriate level of training for team members, completes their training plan on time and ensures proficiency and qualification to perform the production tasks.
• Monitors team training due dates and maintains the trained status of all team members by ensuring appropriate time is allocated to training activities.
• Building a high-performing team and help recruit exceptional people, conducts interviews/reviews candidate suitability, and provides meaningful feedback to current and future employees/leadership, Talent Acquisition and HR partners.
• Build a culture of ethics, decision making, and accountability.
• Responsible for creating/managing Workday profiles for all new hired staff and administering the performance review process, differentiating performance, giving recognition when deserved, and continuous feedback to improve performance and ensure behavior not aligned with the BMS values.
• Conduct regular 1:1 meetings/skip levels with team members, leaders, and stakeholders to mentor, develop/motivate individuals, and enable team members with their professional development.
• Lead troubleshooting activities for the team and provide ownership of Deviations occurring in area, capture the relevant background and potential causal factor information in a timely fashion.
• Author clear, concise, and factually complete description of events that led to the deviation and enter the deviation record information in the system.
• Report out deviation progress, helps maintain proper deviation metrics, identify repeat causes of deviations, and closes out all deviations on time.
• Build trust and productive relationships with peers and stakeholders while driving collaboration across the company and external partners.
• Define strategic projects, change controls, and CAPAs as required to restore area performance and ensure optimal compliance levels.
• Identify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resources to resolve.
• Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability.
• Effectively control expenses within their influence (OT, Supplies, T&E).
• Lead by example, role model leadership behaviors, and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion.

Requirements:

• Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications.
• Advanced knowledge of cryopreservation, material handling, and logistics including best industry practices, application of principles, concepts, practices, standards, validation, and qualification.
• Strong knowledge and application of OSHA, DEA, USP, and other applicable WH regulations.
• Proficiency in ERP systems/WMS Applications, Scheduling, and analytics tools.
• Proficiency in system and application use for business operations.
• Proficiency in MS Office applications.
• Proficiency in analytical, problem-solving, critical thinking skills, and strong situational decision making.
• Proficient organizational and time management skills.
• Strong written and verbal communication skills.
• Intermediate presentation development and delivery skills.
• Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements.
• Ability to travel 15% of time.
• Personal responsibility to work safely and ensure colleagues do the same.
• Champion for continuous improvement activities.
• Develop a deep ownership and understanding of one's work area.
• Establish performance measures and targets to drive improvements.
• Participate in reviews of performance, generate improvement ideas, and take action.
• Use visual management so no problem is hidden.
• Provide data for effective daily Tier 1/2/3 meetings.
• Build a culture of finding root causes and actions to prevent reoccurrence.
• Increase right-first-time performance by adhering to GMP documents and procedures, proactively prevent deviations, identify root causes, and take preventative actions.
• Become a high-performing organization through a commitment to learning and improvement.
• Learn from successes and failures and share knowledge across the VS teams.
• Become the expert of your area and capture knowledge so all team members can benefit.
• Using Lean principles to remove non-value-added activities to improve operational efficiency.
• Apply Lean tools to reduce waste and remove variability in processes.
• Use actual results/process performance data to identify waste, reduce variation, and improve productivity.
• Maintain balanced and unbiased functional relationships, champion a culture of exceptional teamwork and communication across the organization.
• Identify and mitigate risks in production operations that could negatively impact delivery of safe and effective therapies to patients.

Basic Requirements:

• Bachelor's degree in supply chain, engineering, life sciences, information systems, business management, or related fields.
• 5+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
• 5+ years' experience in manufacturing and supply chain areas.
• 3+ years direct supervisor/personal management experience.
• Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• An equivalent combination of education, experience, and training may substitute.

Working Conditions:

• Intermittent walking and sitting to perform job functions.
• Ability to sit or stand for extended periods of time may be necessary.
• Physical dexterity to effectively use computers and documentation.
• Vision and hearing capability to work in job environment.
• Lift maximum of 25 pounds.
• Ability to work around laboratories and controlled, enclosed, restricted areas.
• Wear required cleanroom garments and personal protective equipment in designated areas including cryo aprons, cryo gloves, and face shields.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Exposure to reagents, chemicals, exposure to sanitization agents are expected, and potential exposure to human blood components.
• Areas may prohibit food, any outside materials, cell phones, and tablets.