Director, Manufacturing Sciences & Technology

JOB SUMMARY

Reporting to the site Vice President & General Manager, the Director of Manufacturing Sciences and Technology (MS&T) is responsible for a staff of engineers, scientists, analytical and technical professionals, and specialists with expertise in aseptic/ sterile drug product formulation, vial and syringe filling, and primary packaging manufacturing activities for liquid, lyophilized and suspension products.  The Director, MS&T leads and enables the team to conduct technical assessment of new product placement opportunities into the Baltimore Camden site, whether Emergent BioSolutions, Inc (EBSI) or external client products; introduce and transfer products to the site; and manages and continuously improves the manufacturing science and technical operations to support internal and external / client products.  This role assures MS&Ts strategic alignment to site vision, strategic, and operational plans to assure achievement of site and business objectives.  As part of the site / extended leadership team, the leader assures clarity, alignment and direction is provided to the MS&T team and with partner functions; plans, forecasts and manages resources and MS&T resourcing solutions to support demand and requirements for technical activities; and, collaborates with other functions across the site and within the EBSI network to develop required manufacturing science and technology solutions for the business needs.  The MS&T Director serves the system owner for multiple quality systems including media fill protocols and management, analytical method validation, and Product Process Qualification (PPQ) authorization, including its oversight.  The MS&T leader fosters an environment that encourages innovation with respect to identification, evaluation and implementation of new technologies, new products, and improvement to existing commercial products, and continually partners across functions to assure the site stays abreast of contemporary manufacturing science and technologies in the aseptic / sterile drug product filling environment.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Departmental Leadership Responsibilities
  • Align departmental vision to site strategy and manage the implementation of strategic changes within the manufacturing function
  • Annual departmental goal setting & performance management
  • Oversee evaluation and introduction new molecules and products into the site.  This includes managing the interface of the MS&T group with CMC project management, CMC regulatory and manufacturing.  The MS&T Director manages Technical Project Managers, and the Technology Transfer Analytics and Technology Transfer Process resources responsible for these activities.
  • Drive evaluation, planning, schedule adherence and implementation of improved drug product manufacturing processes for products manufactured from a conceptual idea to filling and primary packaging, in collaboration with key partner functions including but not limited to Manufacturing, Engineering, Quality, Supply Chain, and as required Product Management and Client Relationship & Portfolio Management.  
  • Develop and execute strategies to improve production throughput efficiencies throughout the new product introduction phase along with seeking opportunities to implement efficiencies of existing processes.
  • Manage Technical Product Leaders, responsible for manufacturing science, technical support and improvements associated with internal EBSI products and external client products; includes assuring effective engagement of the TPLs in client-focused operating model and in partnership with Client Portfolio & Relationship Managers and Quality Client Services Specialists.
  • Collaborate with individuals in MS&T to aid with their professional development, including support for each colleagues Individual Development Plans centered on behavioral/leadership competencies as well as the development of new skills and understanding for new technologies
  • Assess talent and support talent development and succession planning activities aligned with annual enterprise and functional schedules.
  • Develop and execute plans, aligned with site and enterprise priorities, which enhance employee/team engagement and enable colleague performance.
  • Effectively plan workforce resources and provide solutions to assure MS&T support for business needs and requirements.
  • Plan and manage annual departmental budget and associated program and project costs for which the MS&T team is accountable.  Oversee development of new technology, technology improvement, and MS&T-related cost and budget estimates for project, program, and site planning.
  • Establish and maintain a safe work environment through the application of our behavior-based safety and 6S+ programs for MS&T team.
  • Demonstrate accountability for personal development by planning and executing actions which support hard and soft skill enhancement, including leadership competencies aligned with Emergent’s leadership core competencies guidance.

• Team Contributions / Management/System Owner Responsibilities:
  • Development and application of effective team, program and portfolio management tools/methodologies which enable effective oversight and execution of new product evaluation, new product/ molecule introduction, and technical product leadership responsibilities. Related methodologies, practices and competencies include:
    • Project prioritization & goal setting
    • Planning and aligning priorities with site, business, and enterprise strategic plans
    • New project charter development, initiation, and launch
    • Resource forecasting, planning and allocation
    • Project execution/milestone tracking
    • Project Closure - value/ROI realization
    • Risk management - elevation, mitigation, etc.
  • Contribute as highly effective member in Value Stream Management structures
  • Timely reporting of team, project, program, and portfolio performance
  • Provision of appropriate oversight for MS&T resources assigned to Hoshin projects to ensure effective project planning, execution, implementation, and closure
  • Coaching and leadership to applicable project teams to ensure strong teamwork and collaboration
• Oversight of system owners for technology transfer, process validation and method validation systems
  • Responsible for the efficiency, effectiveness, and overall compliance of the system
  • Accountability for system performance to KPI targets for Safety, Quality, Delivery, Economics and People
  • Ensuring/Maintaining inspection readiness for each of the systems
  • Managing relationships with system customers and suppliers
  • Review & approval of quality system documentation associated with each of the systems
  • Management of key risks and prioritization & oversight of continuous improvement efforts
  • Establishing and maintaining enterprise-wide communities of learning for each of the systems 
  • Providing timely and effective support to key customers across the site/enterprise (i.e. validation assessments, data analysis, development materials, technology assessments, technical risk assessments, investigation support, product impact assessments, etc.)

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• A degree (Bachelor to Ph.D.) in a related field with a minimum of 10 years industry experience
• Experience in managing scientists/engineers in a fast paced, challenging environment
• Proven track record of management and leadership effectiveness
• Strong knowledge of lean & QbD principles in a manufacturing environment with successful application experience
• Experience with site strategic planning and prioritization (i.e. Hoshin)
• Understands and applies a broad range of financial management principles to ensure decisions are fiscally responsible
• Experience with complex, cross-functional project planning and execution
• Strong collaboration skills within cross-functional/matrixed team environment
• Effective meeting facilitation
• Strong risk management skills (identification, mitigation, elevation, etc.)
• Diverse and demonstrated technical knowledge with strong risk management mindset
• Strong technical and communication skills: oral/written and listening
• Computer skills (MS Office Suite, JMP statistical software, Visio, LIMS, SAP, etc)
• Understanding of MS&T concepts including but not limited to:
  • Technology Transfer Strategy and Implementation
  • Formulation Development, Process Development, Product Process Improvement, QbD / PAT
  • Media Fill programs, compliance requirements, execution elements
  • Process Characterization and Control, Equipment Qualification
  • Process and Analytical Method development and validation
• Knowledge of key aseptic/ sterile drug product liquid and lyo manufacturing technologies
• Experience with various regulatory agencies, audits, and submission, particularly manufacturing process, methods, and or facility/equipment improvements
• Strong knowledge of regulatory guidance associated with process and method validation
• Experience with interface with CMC project management, CMC regulatory and manufacturing
• Quality System experience (i.e. Deviations, CAPA, Change Control)
• Key Skills / Competencies
  • Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
  • Driving workforce engagement, Building effective teams
  • Coaching/teaching/mentoring – modeling the desire behaviors/competencies within and across functions
  • Managing conflict/conflict resolution
  • Building trust and rapport with the workforce
  • Promoting a healthy work environment (i.e. safe, empowered, learning oriented, focused on continuous improvement), Ensuring accountability (Behaviors, Performance, etc.)