Manufacturing Leadership Position

7 days ago

San Diego, California, United States The University of Texas MD Anderson Cancer Center Full time

Job Title:
Director of Manufacturing

Location:
US

Job Description:

The University of Texas MD Anderson Cancer Center seeks a Director of Manufacturing to lead the coordination of manufacturing and release of our cell therapy products. This role will oversee the manufacturing of Capricor's product candidates for early stage and late-stage clinical trials.

Responsibilities:

  • Directly oversee the manufacturing of Capricor's product candidates for early stage and late-stage clinical trials.
  • Lead CMC operations focusing on all areas including but not limited to GMP manufacturing, facility management, procurement, biologics process development, regulatory documentation, validation and change control, and supply chain management.
  • Provide strategic and technical direction for technology transfer (internally and/or to a CMO), process development, and optimization activities.
  • Proactively identify knowledge gaps and risks, and work with the team to develop mitigation plans.
  • Collaborate with R&D/PD department to continuously improve manufacturing processes.
  • Oversee supply chain activities to ensure critical raw materials and reagents are made available to ensure timely execution of manufacturing campaigns.
  • Develop manufacturing plans with resources and supervise schedules to meet clinical demand and new clinical trials on cell/gene therapy and/or related platforms.
  • Evaluate new technologies and novel, relevant applications of existing technologies for potential implementation to improve company's products and processes.
  • Identify and implement process improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance.
  • Work closely with Quality department to ensure compliance with cGMP, ICH, and FDA regulations.
  • Contribute to regulatory filings and interact with regulators as requested to ensure timely start of clinical trials.
  • Define and communicate strategic imperatives to project success.
  • Ensure clear communication to Company's senior management on the status of clinical inventory, manufacturing projects, and goals as they relate to cross-functional business success.
  • Perform other such duties as may be assigned to you.

Requirements:

  • Bachelor's degree required (PhD preferred).
  • 8+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry.
  • 5+ years of direct management of manufacturing professionals with a range of responsibilities.
  • Exceptional communication and interpersonal skills.
  • Ability to collect and analyze data and information to determine paths for process improvement and potential root cause.
  • Demonstrated critical thinking and problem-solving skills.
  • Must have full working knowledge of cGMP regulations.
  • Must have a strong scientific background with knowledge of biologics, cell or gene therapy, and nucleic acid (mRNA) experience a plus.

  • Chemical Production Supervisor

    7 days ago

    San Diego, California, United States Rasirc Full time

    Job DescriptionRASIRC is seeking a highly skilled Chemical Production Supervisor to oversee the manufacturing of RASIRC Chemicals and manage day-to-day operations.Key Responsibilities:Manage all aspects of chemical production, including scheduling, blending, and equipment maintenance.Supervise manufacturing activities, ensuring timely order fulfillment and...

  • Manufacturing Engineer

    3 weeks ago

    San Diego, California, United States Actalent Full time

    Job Title: Manufacturing Engineer IIIThe Manufacturing Engineer III will play a key role in developing innovative engineering solutions to enhance the manufacturing process for new and existing aerospace products. This will involve leveraging data analysis and problem-solving skills to drive engineering judgment calls. Collaboration with design teams and...

  • Manufacturing Engineer

    2 weeks ago

    San Diego, California, United States Actalent Full time

    Job Title:Manufacturing Engineer IIIJob Description:The Manufacturing Engineer III will play a key role in developing and implementing engineering solutions to improve the manufacturing process for new and existing aerospace products. This will involve using data analysis and problem-solving skills to make informed engineering judgment calls.Collaboration...

  • Director of Manufacturing Engineering

    1 month ago

    San Diego, California, United States Argen Corporation Full time

    Job DescriptionArgen Corporation is seeking a highly skilled and experienced Director of Manufacturing Engineering to join our team. As a key member of our leadership team, you will be responsible for overseeing the development, implementation, and maintenance of manufacturing processes to meet company targets for quality, performance, and cost.Key...

  • Manufacturing Engineering Director

    1 month ago

    San Diego, California, United States Unavailable Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineering Manager to join our team at Unavailable. The successful candidate will be responsible for planning, designing, and constructing manufacturing facilities and related structures, as well as determining facility specifications and resolving technical problems.Key ResponsibilitiesSupervise the...

  • Manufacturing Engineering Director

    1 week ago

    San Diego, California, United States General Dynamics - Ordnance and Tactical Systems (CA) Full time

    Job SummaryGeneral Dynamics - Ordnance and Tactical Systems (CA) is seeking a skilled Manufacturing Engineering Manager to lead the development and implementation of industrial manufacturing processes. The ideal candidate will have a strong background in manufacturing engineering, leadership skills, and experience in a relevant function.Key...

  • Global Sourcing Director

    7 days ago

    San Diego, California, United States Qualcomm Full time

    Job Summary:The Global Sourcing Director is a senior leadership position responsible for constructing and operating processes, systems, and customer interfaces to support Qualcomm's growth.This role will be instrumental in developing, providing, and executing sourcing strategies, options, and working with internal customers to conclude decisions based on...

  • Manufacturing Engineering Manager

    1 month ago

    San Diego, California, United States General Dynamics - Ordnance and Tactical Systems (CA) Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineering Manager to join our team at General Dynamics - Ordnance and Tactical Systems (CA). The successful candidate will be responsible for supervising the development and implementation of industrial manufacturing processes to maintain proper product functionality and cost efficiency.Key...

  • Manufacturing Engineering Director

    2 weeks ago

    San Diego, California, United States Unavailable Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineering Manager to join our team at Unavailable. The successful candidate will be responsible for planning, designing, and constructing manufacturing facilities and related structures, as well as determining facility specifications and resolving technical problems.Key ResponsibilitiesSupervise the...

  • Manufacturing Operations Director

    2 weeks ago

    San Diego, California, United States Al Solutions Full time

    Job Title: Vice President of ManufacturingAl Solutions is seeking a highly experienced Vice President of Manufacturing to lead its manufacturing operations in San Diego. The successful candidate will be responsible for overseeing all GMP Manufacturing, MSAT, and Facility & Engineering operations at the site.Key Responsibilities:Lead the Manufacturing, MSAT,...

  • Financial Leadership Position

    2 weeks ago

    San Diego, California, United States Vaco Full time

    Job Title: ControllerAt Vaco, we are seeking a highly skilled and experienced Controller to lead our accounting department. As a key member of our team, you will be responsible for ensuring accurate and timely financial reporting, while maintaining robust internal controls.Key Responsibilities:Oversee the preparation of financial statements in compliance...

  • Manufacturing Engineer

    1 month ago

    San Diego, California, United States Proven Recruiting Full time

    Manufacturing Mechanical EngineerThis pioneering company in the Medical Device industry is seeking a talented Mechanical Engineer to contribute to product design and development processes. As a key member of a tight-knit community of skilled experts, you will have the opportunity to support and promote innovation in the field.Key Responsibilities:Develop,...

  • Manufacturing Engineering Director

    2 weeks ago

    San Diego, California, United States Unavailable Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineering Manager to join our team at Unavailable. The successful candidate will be responsible for planning, designing, and constructing manufacturing facilities and related structures, as well as determining facility specifications and resolving technical problems.Key ResponsibilitiesSupervise the...

  • Manufacturing Engineer

    4 weeks ago

    San Diego, California, United States General Atomics and Affiliated Companies Full time

    Job Title: Manufacturing EngineerGeneral Atomics and Affiliated Companies is seeking a highly skilled Manufacturing Engineer to join our Electromagnetic Systems (EMS) Group. As a key member of our team, you will be responsible for providing manufacturing engineering support to our programs and projects, including missile defense systems, lasers, advanced...

  • Manufacturing Director

    2 months ago

    San Diego, California, United States Trova Talent Full time

    Job SummaryTrova Talent is seeking a seasoned Manufacturing Director to lead our biologics manufacturing efforts. As a key member of our team, you will be responsible for overseeing the production of cell therapy and exosome products, ensuring quality and compliance, and driving continuous manufacturing improvements.Key ResponsibilitiesManufacturing...

  • Senior Production Supervisor

    4 weeks ago

    San Jose, California, United States Western Digital Full time

    Job SummaryWe are seeking a highly skilled and experienced Manufacturing Supervisor to join our team at Western Digital. As a key member of our manufacturing operations, you will be responsible for coordinating between manufacturing, maintenance, and engineering teams to improve production efficiency, quality, and throughput.Key ResponsibilitiesLead a team...

  • Software Engineering Leadership Position

    7 days ago

    San Diego, California, United States Goddard Inc. Full time

    About the Role:The Director of Software Engineering at Goddard Inc. is a leadership position responsible for overseeing all aspects of software and firmware development within the company. This role requires a seasoned professional with extensive experience in software engineering, a strong understanding of software development methodologies, excellent...

  • Director of Manufacturing Operations

    2 months ago

    San Diego, California, United States Argen Corporation Full time

    Job DescriptionArgen Corporation is seeking a highly skilled Director of Manufacturing Engineering to join our team. This is an exciting opportunity to lead the development, implementation, and maintenance of manufacturing processes to meet company targets for quality, performance, and cost.Key Responsibilities:Manufacturing Process Development: Oversee the...

  • Manufacturing Engineer

    2 weeks ago

    San Diego, California, United States Proven Recruiting Full time

    Manufacturing Mechanical EngineerThis pioneering company in the Medical Device industry is seeking a talented Mechanical Engineer to contribute to product design and development processes. As a key member of a tight-knit community of skilled experts, you will have the opportunity to support and promote innovation.Key Responsibilities:Develop, evaluate, and...

  • Electrical Engineering Leadership Position

    1 week ago

    San Diego, California, United States Metric Geo Full time

    Electrical Engineering Leadership PositionAt Metric Geo, we are seeking a skilled Lead Electrical Engineer to oversee the design of major projects, manage project budgets, and provide technical leadership. This role requires a professional engineering license, a minimum of 8 years' experience in a consulting firm, and 3+ years in supervisory or project...