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Director, Manufacturing

Company: Kaleido Biosciences
Location: Lexington
Posted on: April 8, 2021

Job Description:

Kaleido Biosciences is a clinical-stage healthcare company with a differentiated, chemistry-driven approach to leveraging the potential of the microbiome organ to treat disease and improve human health. The Company's Microbiome Metabolic Therapies (MMT---) are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the organ's existing microbes. Kaleido is advancing a broad pipeline of MMT candidates to address a variety of diseases and conditions with significant unmet patient needs. The Company's human-centric discovery and development offers the potential to be faster and more cost-efficient than traditional drug development. We also have an exceptional team that is committed to scientific innovation, transforming lives, and building a strong culture . Overview : Kaleido Biosciences is seeking a highly motivated and talented Director , Manufacturing who will be responsible for the company's manufacturing operations to ensure delivery of the clinical products. The incumbent will be responsible for driving strategies, technical and operational management for internal small molecule GMP manufacturing operations for pre-clinical and clinical studies . The incumbent will be responsible for leading and coordinating the required resources to develop and execute the near and long-term strategy to maximize manufacturing outcomes, and proactively plan for changing conditions. This position requires collaborative skills, multi-tasking ability, and desire to strive in a fast-paced environment. The successful candidate will bring a strong background of GMP manufacturing . We are an early-stage company, so this is a highly visible and impactful role in our organization. Summary of Key Responsibilities:

  • Assume overall responsibility for the technical and operational management of GMP manufacturing operations for drug substance and drug product materials supporting clinical studies.
  • P rovid e hands on leadership and oversight/execution of operational targets and milestones
  • Oversight and management of the production staff to meet the site schedule and objectives . Ensure resources are being utilized on the most impactful activities.
  • Management of production area in a safe and compliant manner
  • Set clear objectives, monitor, and report on performance of the Operations team in key areas including Quality, Safety, Delivery, and People. Mitigate and escalate risks to the appropriate leve l
  • Oversee hiring to build an effective manufacturing team; create and communicate a clear vision among direct reports, effectively align resources, and motivate teams to achieve goals
  • Manage product life cycle from transfer of processes from process development laboratory to internal and external production; includes but is not limited to process maps, risk assessment, safety review, generation of batch records and SOP s, change controls, process controls, process validation
  • Provide technical guidance for complex manufacturing operations
  • I nvestigate and resolve problems, identifying the root cause, and proposing process improvements through clear communication to the Leadership Team.
  • Resource planning, staff development and talent and performance management
  • Drive for continuous improvement and operational efficiency to eliminate waste and reduce COGS with the manufacturing operations
  • Develop and maintain performance metrics for site manufacturing activities and communicate department progress to management and staff.
  • Proactively identifies and drives continuous improvement opportunities and effectively leads timely resolution of production issues
  • P repare technical reports, publications, and oral presentations
  • Reviewing and approving documents related to GMP operations as requested including process development report s , MBRs, and campaign summary report Qualifications:
    • PhD and 10 + years of experience or MS degree with 14 + years of experience in Chemistry, Chemical Engineering , Pharmaceutical Sciences or equivalent.
    • Extensive e xperience in a small molecule pharmaceutical CMC/GMP manufacturing environment and in-depth business understanding of manufacturing or operations in the pharmaceutical industry.
    • Demonstrated ability and hands-on experience in small molecule CMC development and GMP manufacturing
    • S ignificant knowledge of drug substance and drug product manufacturing processes.
    • H ave a track record in devising and implementing CMC strategies from concept phases through GMP manufacturing for development candidates.
    • K nowledgeable with FDA, EMEA, ICH and other relevant CMC/Quality regulations and guidelines. You have experience with IND/CTA/NDA filings.
    • A team player who is willing to roll-up your sleeves and get the job done
    • T ake pride in mentoring and growing the careers of those who work in your organization.
    • Strong project management, interpersonal, presentation and communication skills
    • Ability to partner with the business functions to enable high-quality outcomes Kaleido Biosciences is an EEO employer committed to an exciting, diverse, and enriching work environment. You have been redirected to a Kaleido Biosciences job page

Keywords: Kaleido Biosciences, Huntsville , Director, Manufacturing, Executive , Lexington, Alabama

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