Director, Manufacturing Science & Technology

Location: 

Lansing, MI, US, 48906


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The primary responsibilities associated with the role of Director of Manufacturing Sciences and Technology (MS&T) are listed as follows.

  • Oversight for development and application of various manufacturing processes for realization of products in support of Emergent’s primary mission
  • Establish, lead, and manage a team of technical staff, engineers, scientists and lab managers with expertise in upstream/ downstream manufacturing, analytics, formulation development and fill and finish.  Workforce management and development for direct reports within the MS&T function
  • Departmental strategic alignment to site vision/strategy and management of strategic changes within the MS&T function
  • Leadership role on the Hoshin Steering Team with accountability for the oversight and performance of our Hoshin Project Portfolio
  • System owner responsibilities for multiple quality systems within the MS&T function (e.g. Process Validation, Technology Transfer, Method Validation, Cell Banking)
  • Fostering an environment that encourages innovation with respect to identification, evaluation and implementation of new technologies, new products, and improvement to existing commercial products
  • Leading the development of strong rapport/collaborative relationships with external and internal partners (i.e. MS&T leaders/teams across the enterprise, internal customers, external agencies, and organizations, etc.). Provide management of resources dedicated to technical activities and establish close collaboration with other operating units, external industry biologics consultants and biologics academic partnerships globally
  • Management and oversight of small/mid-scale manufacturing Pilot Plant operations, ensure success of scale up/process transfer to routine CGMP manufacturing
  • Operate as and represent the MS&T function as part of the site leadership team
  • Oversight for Process Performance Qualification (PPQ), Continued (Ongoing) Process Verification (CPV/OPV) and Annual Product Reviews (APRs)/Product Quality Reviews (PQRs/APRs) for all manufacturing processes/products.
  • Oversight for introduction of improved drug substance manufacturing processes for biologics manufactured from a conceptual idea to filing. This includes managing the interface of the MS&T group with CMC project management, CMC regulatory and manufacturing.

 

 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 (i.e. 1-1’s, mid-year assessments and year-end evaluations)
    • Talent Management: development of talent from entry level to lead positions
    • Personnel Development: individual development plans centered on behavioral/leadership competencies as well as the development of new skills and understanding for new technologies
    • Establishing & maintaining employee/team engagement
    • Personal Development: development against core leadership competencies through your individual development plan
    • Establishing and maintaining a safe work environment through the application of our behavior-based safety and 6S+ programs
    • Effective workforce planning and resource allocation relative to project and production related support
    • Review and management of monthly departmental spend within budget
    • Serves as a representative for the Manufacturing Operations function on site/enterprise level activities/initiatives
  • Portfolio Management/System Owner Responsibilities:
    • Leadership role on the Hoshin Steering Team: 
    • Development & application of effective portfolio management tools/methodologies
      • Project portfolio oversight including:
        • Alignment to site strategic plan
        • Project prioritization & goal setting
        • Project sanctioning and initiation
        • Resource allocation
        • Project execution/milestone tracking
        • Project Closure - value/ROI realization
        • Risk management - elevation, mitigation, etc.
  • Establishment of strong rapport with key customers and suppliers (i.e. VSMC, system owners, SLT, functional managers) 
  • Monthly reporting on portfolio performance
  • Provides appropriate oversight for MS&T resources assigned to Hoshin projects to ensure effective project planning, execution, implementation, and closure
  • Provides necessary 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 Peopleo    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 (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
    • Process Characterization and Control, Equipment Qualification
    • Process and Analytical Method development and validation
  • Knowledge of key biologics manufacturing technologies
  • Experience with/oversight for introduction of improved drug substance and drug product manufacturing processes for biologics manufactured from a conceptual idea to filing
  • 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.)
       

 

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Lansing