Director, Manufacturing Sciences and Technology (MSAT)

Company: Maravai LifeSciences
Location: San Diego
Posted on: January 27, 2023

Job Description:

TriLink Biotechnologies, a Maravai LifeSciences company is seeking a Director, Manufacturing Sciences and Technology (MSAT) to join our growing team.The Director of Manufacturing Science and Technology (MSAT) is a leadership role and will be responsible for technical leadership and support of Contract Development and Manufacturing Organization (CDMO) manufacturing operations for Nucleic Acid Products (NAP) and Nucleic Acid Services (NAS). The candidate will be responsible to lead, manage and develop a department of employees responsible for MSAT activities in alignment with NAP and NAS.
The role will report into the Engineering organization and focus on liaising with internal and external clients to transfer and support their respective manufacturing processes.
Description of Duties:

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• Act as a subject matter expert in plasmid, mRNA production, and small molecule manufacturing operations and sciences
  
• Manage a team; lead, develop and implement scientifically sound and phase appropriate process validation policies and procedures based on current regulations, industry standards and industry practices.
  
• Hands-On leader with high level of engagement within MSAT function and cross-functionally.
  
• Provide mentorship and developmental feedback to create and foster a collaborative work environment. Responsible to coach, mentor, collaborate, partner, at all levels with high visibility and engagement.
  
• Partners in the development and execution of long-term MSAT strategy in line with NAP and NAS initiatives to include new technology and process introduction into manufacturing.
  
• Active management of employees, reflecting on problems, solutions, and challenges.
  
• Accountable for creating a culture of continuous improvement, that contributes towards becoming a learning organization.
  
• Continuously seek to optimize the manufacturing processes to ensure effective use of capacity and minimize costs.
  
• Provide leadership and direction for Site MSAT and manufacturing Technical SMEs to define the process validation requirements.
  
• Interface cross-functionally with Process Development, Quality, Manufacturing, and Process Engineering to implement new processes and technology.
  
• Explore, assess and recommend new manufacturing unit operations which improves manufacturing processes from a cost, efficiency, quality, and compliance.
  
• Prepare and present regular updates indicating progress, risks, and future plans for NAP and NAS projects.
  
• Accountable for technical review of manufacturing batch records, SOPs, deviations, and investigations.
  
• Accountable for design and oversee experiments in collaboration with Process Development/Process Engineering to support investigations and process improvements.
  
• Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and robustness for NAP and NAS
  
• Accountable of robustness and capability of product's monitoring while using statistical analysis to monitor Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs).
  
• Identify and implement process improvements to support NAP and NAS.
  
• Support change controls, audits, deviations, and Quality Risk Management programs
  
• Own Quality by design program for NAP and NAS.
  
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
  
  Job Qualifications:
  
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  • BS./M.S./Ph.D. in Biochemistry, Chemical/Biomedical Engineering or Biology or equivalent with 15+ years process validation, technology transfer or biotech/pharmaceutical manufacturing experience.
    
  • 6+ years of directly related industry experience in GMP manufacturing with direct/indirect experience managing a team as well as leadership experience leading teams, projects and programs.
    
  • Cell culture, cell therapy, or aseptic and final fill processing experience (preferred)
    
  • Solid understanding of principles and concepts of Lean Six Sigma to improve process capability (preferred)
    
  • Thorough understanding of cGMP manufacturing (must).
    
  • Excellent communication and written skills with direct experience supporting significant strategy development & implementation.
    
  • Thorough understanding of regulatory/compendial requirements used in biotech/pharmaceutical manufacturing.
    
  • Experience leading technical transfers, qualification, validation, and implementing multivariant process monitoring (must)
    
  • Strong interpersonal and leadership skills to work with teams in different functions and organizations.
    
  • Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
    
  • Lean Manufacturing experience is desired.
    
  • Experience with manufacturing automation and Manufacturing Execution Systems (MES)
    
  • Knowledge of data management tools and statistical process
    
  • Willingness to think outside of the box and adapt best practices in a novel technology environment.
    
  • Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus
    
    The anticipated salary range for this position is 195,000 - 220,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.

Keywords: Maravai LifeSciences, San Diego , Director, Manufacturing Sciences and Technology (MSAT), Executive , San Diego, California