Senior Staff Engineer

Company: Takeda
Location: Cambridge
Posted on: November 20, 2023

Job Description:

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Job Description

Objective:

Synthetic Molecule Process Development (SMPD) is responsible for the development of robust and cost-effective processes for the manufacture of new small molecule pharmaceuticals, along with methods for achieving and controlling high standards of purity and quality.

The successful candidate will be responsible for all aspects of reaction & particle engineering including the development of scale down models for the study of unit operations as well as technical transfer to external contract manufacturing organizations. He/ she will have deep experience in using process analytical technologies (PAT) in combination with mathematical models (both statistical & first principle) to enhance process understanding to effectively develop/ optimize/ scale-up and troubleshoot processes. The Senior Engineer will have experience building scale-down equipment and developing innovative advanced process control strategies for both batch and continuous processes.

They will be recognized as a technical resource/expert within SMPD and across Pharmaceutical Sciences and utilize his/ her technical expertise to contribute across multiple projects and drive technical/scientific strategy. The Senior Engineer will be responsible for benchmarking current trends in research, development and manufacturing technologies, developing initiating and/or participating at a high level in projects that involve extraordinary, well-considered risks along with scientific/technical challenges, as well as directing and managing outsourcing across a product platform, as appropriate.

Accountabilities:

• Develops project or significant technical strategy and leverages technical skill(s) as a resource/expert within the department
  
• Contributes significantly and independently to project work which may include multiple projects within functional area.
  
• Plans and implements resolutions to technical problems/issues
  
• Independently designs and executes experiments, and reports results
  
• Recommends, justifies and implements technologies and innovations.
  
• Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills.
  
• Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
  
• Reviews, interprets and communicates data cross functionally within pharmaceutical sciences and project teams
  
• Conducts analysis of technical and conceptual risk and trends
  
• Identifies process trends and defines/champions process strategy or use of novel technologies
  
• Recognized as a technical expert and resource within function
  
• Significant technical responsibility for a project area/technical program within the department and potentially across Pharmaceutical sciences
  
• Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff.
  
• Defines appropriately complex/novel approaches and methodologies to solving outstanding technical challenges
  
• Coordinates and leads technology transfer to internal or external manufacturing sites
  
• Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts.
  
• Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
  
• Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.
  
• Represents Takeda and is an active member on pre-competitive collaborations with academic and industrial partners.
  
  
  Education and Experience:
  
  Required:
  
  • A Ph.D. degree with 3+ years of academic, post-doctoral or pharmaceutical industry experience; an MS degree with 9+ years of pharmaceutical industry experience; or a BS degree with 11+ years years of pharmaceutical industry experience. Degrees in chemical engineering required.
    
  • Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems preferred
    
  • Experience in building reaction kinetic models as well as process models preferred.
    
  • Experience in building laboratory and pilot plant equipment a plus
    
  • Experience in crystallization process development and scale-up with an emphasis on form, purity and particle size control a plus
    
  • Experience in the use and scale-up of milling technologies (both dry and wet) for particle size control a plus
    
  • Experience in the use of process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.) required
    
  • Experience in building chemometric models preferred
    
  • Experience in developing continuous processes a plus
    
  • Sound knowledge of current Good Manufacturing Practices (cGMP) preferred
    
  • Experience working in a pilot plant a plus
    
  • Previous experience with the use of contract facilities and managing technical transfers a plus
    
  • Experience in working in a multi-disciplinary team environment
    
  • Proven scientific track record through presentations at scientific conferences and publication of pier reviewed manuscripts
    
    
    Knowledge and Skills:
    
    • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions
      
    • Teamwork -- Ability to work well on global cross-functional teams.
      
    • Communication Skills -Able to expresses one's self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with senior management; technical writing skills to support authorship and approval of internal technical documents
      
    • Organization - Exercises good time management and prioritization skills to balance multiple project and departmental objectives
      
    • Technical - Subject matter expertise in a specific scientific area or areas.
      
    • Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
      
    • Resource Management -Project management skills; ability to manage one's time within individual, departmental
      
    • External Involvement - Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects
      
    • Leadership Skills - Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.
      
      
      Travel Requirements:
      
      May require approximately 10% travel.
      
      What Takeda can offer you:
      
      • Comprehensive Healthcare: Medical, Dental, and Vision
        
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
        
      • Health & Wellness programs including onsite flu shots and health screenings
        
      • Generous time off for vacation and the option to purchase additional vacation days
        
      • Community Outreach Programs and company match of charitable contributions
        
      • Family Planning Support
        
      • Flexible Work Paths
        
      • Tuition reimbursement
        
        
        More about us:
        
        At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
        
        Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
        
        In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
        
        EEO Statement
        
        Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
        
        Locations
        
        Cambridge, MA
        
        Worker Type
        
        Employee
        
        Worker Sub-Type
        
        Regular
        
        Time Type
        
        Full time

Keywords: Takeda, Cambridge , Senior Staff Engineer, Engineering , Cambridge, Massachusetts