Sr. Manager - Drug Product Ops

The Sr. Manager – Drug Product Operations is recognized as subject matter expert with regard to manufacturing processes and system owner.  The Manager will:

• Ensure delivery of production execution schedule and adherence to daily and weekly schedule.
• Initiate and oversee implementation of new technology and modifications to existing technology aimed at cost reduction, efficiency improvements, minimization of downtime and quality/safety enhancement.
• Make recommendations regarding departmental profit plan, capital planning, budget, and standards development.
• Recognizes and investigates opportunities for financial savings across a broad spectrum of operational activities.
• Be able to identify and communicate improvement opportunities and results.
• Coordinate and lead production training across shifts.
• Identify operational needs for special projects (new product sub team, capital projects, etc.) ensuring site/divisional linkage is achieved.
• Mentor and train new managers and other new departmental employees.

External US

Essential Functions:

Employee Development/Management

• Coaches managers and coordinator(s) in a learning culture with the goal of achieving employee empowerment

and ownership;

• Assists the manager with development of objectives and ensures alignment with site and department goals;
• Provides ongoing formal and informal feedback to direct reports; including 1:1's
• Assesses employee training/development needs, assesses the maturity of the team, and adjusts leadership style to enhance team performance;
• Recognizes and addresses direct report performance
• Responsible for preparing and presenting process trends and present results for active processes for real time process monitoring.
• Ensure appropriate Level IV and V technicians between shifts
• Maintain budgeted headcount while assessing and providing input for increase as processing requires

Production Performance Ownership

• Be the primary contact for production managers on shift to escalate issues or events;
• Observes critical operations, with production managers;
• Responsible for detailed 7 day weekly schedule and reporting schedule adherence to against plan.
• Responsible coordinating task and events with other entities (maintenance, process sciences, MTS, QC and others)
• Oversees coordination of resources to implement suggestions/ideas of process improvements;
• Leads, coordinates and implements manufacturing process and compliance improvements.
• Manages, tracks and reports adherence to metrics, design standards and performance utilizing downtime tracking, MOE, SMED, and other available tools;
• Responsible for client specific media control and resin inventory and control;
• Responsible for cycling monitoring (flask, process or columns);
• Responsible sustaining for suite ownership and inspection ready state
• Approves and authors documents including but not limited to: s protocols, work instructions, SOPs ;
• Ensure the termination of MO's in Pas-X post execution
• Ensure continuous improvement of standard work and other visual management tools used by mfg. for operations

Information Transfer

• Works with readiness coordinators and process sciences to ensure manufacturing technology transfer success and right first time execution.
• Participate and lead in PPA, PA and FEMA, stage gate and client events, to ensure manufacturing readiness success;
• Serves as liaison between shifts, teams and other departments and interacts with clients, in select project meetings.
• Attends/provide input departmental, team and cross functional meetings, to include equipment/process improvement
• Cross departmental communication to ensure process and operational success
• Ensure good communication and understanding between managers to include other mfg. areas to maximize efficiency between US and DS i.e. resources, process timelines, etc.

Compliance

• Leads critical investigations for atypical, observation, and process capability investigations;
• Oversight of compliance metrics and work with Quality Management to establish priorities and improve systems.
• Reviews safety investigations and safety and environmental program compliance for manufacturing;
• Participates in internal and external audits and inspections;
• Identifies quality-related trends and responsible for on time completion compliance related actions
• Periodic GEMBA critical operations to ensure deviation free/ right first time performance and build skill with technicians
• Ensure initiation, review and approval for atypical, observation, and execution of human error events are completed and within timelines, and support process and equipment related events.

Required Skills & Abilities:

• Extensive, demonstrated experience in the life cycle of drug product operations.
• Clear leadership qualities and demonstrated success in management including both role power and influence with colleagues.
• Demonstrates managerial maturity in fast-paced development and operational environments.
• Requires strong analytical and communication skills including both oral and written.
• Ability to translate high-level guidance into executable plan including buy-in from stakeholders.
• Ability to prioritize work to meet deadlines.
• Demonstrated ability break up complex activities into delegated pieces to enable timely execution.
• Transparent, detail oriented and accurate.
• Excellent computer skills and proficient in MS Office (Work, Excel, Outlook, PowerPoint) and MES/data historian use.
• Strong interpersonal skills with an understanding of diverse backgrounds and an emphasis on communication: training, team building, negotiation skills, interdepartmental interactions, leadership and management.
• Ability to hire, train, and develop employees to grow within the organization

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  While performing the duties of this job, the employee is required on a regular basis to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required
• May be required to lift up to 40 pounds on occasion
• Attendance is required.

Minimum Qualifications:

• Bachelor's Degree in science, engineering or other technical field plus seven years (7) of coaching/supervisory experience in a related technical field.
• Associate's Degree or military technical training in science, engineering or related technical field with a minimum of 10 years (10) coaching/supervisory experience in a related technical field.

Demonstrated leadership, interpersonal, technical aptitude, and problem solving skills.  Strong team skills, including ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict.  Must be flexible and able to manage multiple priorities.  Must be goal-oriented and able to manage risks.  Excellent verbal and written communication skills. Able to work 12+ hour shifts, day or night, periodically. 

Preferred Qualifications:

• Represented DPO during regulatory inspection.
• Authored in part or whole CMC sections for DPO.
• Experience working with isolated filling systems.
• Validation and/or QA leadership.
• Both CMO and Development company experience.