Engineering Director jobs in the United States

Engineering Director plans and directs all aspects of engineering activities and projects within an organization. Ensures all engineering projects, initiatives, and processes are in conformance with organization's established policies and objectives. Being an Engineering Director utilizes best practice engineering methods and provides expert technical guidance for engineering initiatives. Incorporates components, materials, and tools that result in cost-effective and quality output. Additionally, Engineering Director manages overall engineering budget and costs. Requires a bachelor's degree in engineering or related discipline. Typically reports to top management. The Engineering Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be an Engineering Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. (Copyright 2024 Salary.com)

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Executive Director, Process Engineering
  • 10001097 - Senior Director Science
  • Gaithersburg, MD FULL_TIME
  • If you have the passion and the drive to accelerate growth and make people’s lives better – then AstraZeneca is the place for you.  In Operations we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking. 

    AstraZeneca turns molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery.  Operations is accelerating, fast. We are on track for Our Bold Ambition 2030, delivering 15 new medicines driving us forward across different modalities including biologics, cell therapy, ADCs and small molecules. 

    Position Summary

    We are looking for an experienced Executive Director of Process Engineering to lead our cell therapy process engineering team. The Executive Director will oversee the design, scale-up, and optimization of cell therapy manufacturing processes.  This is a new leadership position responsible for building out a team.  You will help ensure that our cell therapy products are manufactured, cost-effectively, from early development through commercialization.

    The Executive Director will collaborate with teams, including R&D, Quality, Manufacturing, and Regulatory Affairs, to the successful development of process engineering solutions. We are looking for an understanding of cell therapy manufacturing, advanced process technologies, and regulatory requirements, and experience in leadership. You will report to the Vice president of Analytical and Process Development. The position can be based in Gaithersburg, MD or Santa Monica, CA.

    Responsibilities

    • Lead the Late-Stage Process Development function for Cell Therapies within the CTO, managing multiple development projects across several locations.
    • Create and deploy global technical standards for cell therapy, focusing on process validation, sterility assurance, raw materials, single-use technology, and packaging, all within established quality systems.
    • Design and oversee process validation, qualification, and monitoring strategies, implementing master validation plans for processes, equipment, and facilities in collaboration with Subject Matter Experts.
    • Build and manage a multi-site organization that supports the product portfolio, ensuring efficient processes, knowledge exchange, and integration of lessons learned.
    • Oversee resource allocation and make strategic "make vs. buy" decisions based on project priorities and technology strategies, adhering to  CTO CGT governance processes.
    • Drive innovation by integrating internal and external expertise, incorporating the latest technologies, and leading digital programs aligned with CTO CGT strategies.
    • Ensure compliance with all relevant regulations (e.g., ISEC, GMP, HSE), and manage regulatory submissions, including the creation of source documents and dossier modules.
    • Provide technical leadership for developing new and improved processes for high-quality cell therapy production.
    • Author and review regulatory CMC packages for IND filings and approval applications (BLA/MAA/NDA).
    • Address process development inquiries from health authorities during global product filings and approvals.
    • Oversee and ensure the delivery of process development, qualification, and transfer from Process Development to Operations for GMP manufacturing of clinical and commercial cell therapy products.
    • Fulfil all post-approval commitments for commercial products to health authorities.

    Preferred Requirements

    • Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field, or a Master’s degree with relevant industry experience.
    • 10 years of experience in process engineering preferred, with at least 10 years in a leadership role within the biotechnology or pharmaceutical industry with a focus on cell therapy or biologics.
    • Experience in cell therapy or biologics manufacturing, including process design, scale-up, and optimization.

    Skills and Competencies

    • Knowledge in GxP compliance and data integrity.
    • Proven track record in managing and leading a large, high-performing team (30 members) with preferred expertise in CAR-T and human stem cell therapies, biologics, process development, transfer, validation, and automation.
    • Demonstrated ability in developing value-added manufacturing processes from scratch.
    • Diversified experience in a wide spectrum of CMC development suitable for adequately producing cell therapeutics.  

    When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the Gaithersburg, MD or Santa Monica, CA office. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

    The annual base salary for this position ranges from $269,000 to $328,900. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an “at-will position” and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

  • 1 Month Ago

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Senior Director, Bioconjugation, Biologics Engineering
  • 10001074 - Director Bioscience
  • Gaithersburg, MD FULL_TIME
  • Senior Director, Bioconjugate Therapeutics, Biologics Engineering Location: Gaithersburg, MD/Waltham, MAAt AstraZeneca, we work together across global boundaries to make an impact and find answers to ...
  • 21 Days Ago

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Civil Rights Investigator- Detroit
  • Project Director - Engineering Licensed Specialist...
  • Detroit, MI FULL_TIME
  • Salary $49,795.20 - $76,419.20 Annually Location Detroit, MI Job Type Limited Term (position has expiration date) Job Number 1501-24BK-ENF16 Department Civil Rights Opening Date 08/23/2024 Closing Dat...
  • 1 Month Ago

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Director of Engineering
  • Sterling Engineering
  • Carrollton, GA FULL_TIME
  • Shape the Future of Food ManufacturingAre you a visionary engineering leader ready to make a significant impact? We're seeking a dynamic Director of Engineering to lead our team and drive innovation a...
  • 9 Days Ago

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Director of Engineering
  • Van-Am Tool & Engineering
  • Joseph, MO FULL_TIME
  • Join Van-Am Tool & Engineering as the Director of Engineering in St. Joseph, MO, where you'll lead a team dedicated to innovation in metal fabrication and advanced engineering solutions. This onsite r...
  • 15 Days Ago

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Director of Engineering
  • Van-Am Tool & Engineering
  • Saint Joseph, MO FULL_TIME
  • Join Van-Am Tool & Engineering as the Director of Engineering in St. Joseph, MO, where you'll lead a team dedicated to innovation in metal fabrication and advanced engineering solutions. This onsite r...
  • 18 Days Ago

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Principal Engineer - Mobile iOS
  • Marriott
  • Columbus, OH
  • Job Number 24164217 Job Category Information Technology Location Marriott International HQ, 7750 Wisconsin Avenue, Bethe...
  • 10/30/2024 12:00:00 AM

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Civil Engineer - Project Manager
  • Congruex
  • Columbus, OH
  • Description Job Title: Project Manager Department: Engineering Reports To: Director of Engineering or Program Manager Em...
  • 10/29/2024 12:00:00 AM

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Project Manager
  • Congruex LLC
  • Columbus, OH
  • Job Title: Project Manager Department: Engineering Reports To: Director of Engineering or Program Manager Employment Sta...
  • 10/28/2024 12:00:00 AM

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Director of Product Management
  • Collinwood Technology Partners, LLC
  • Westerville, OH
  • Collinwood is assisting our client, a manufacturer of sensors/compoinents, as they seek to hire a Director of Product Ma...
  • 10/28/2024 12:00:00 AM

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Project Manager
  • Congruex
  • Columbus, OH
  • Description Job Title: Project Manager Department: Engineering Reports To: Director of Engineering or Program Manager Em...
  • 10/27/2024 12:00:00 AM

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Asbestos and Hazardous Materials Coordinator Facilities Design and Construction
  • The Ohio State University
  • Columbus, OH
  • Screen reader users may encounter difficulty with this site. For assistance with applying, please contact hr-accessiblea...
  • 10/27/2024 12:00:00 AM

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Senior Specialty Solutions Engineer - Digital Solutions
  • AHEAD
  • Columbus, OH
  • AHEAD builds platforms for digital business. By weaving together advances in cloud infrastructure, automation and analyt...
  • 10/27/2024 12:00:00 AM

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Project Manager (Solar)
  • MasTec Inc.
  • Columbus, OH
  • Overview The Project Manager serves as the single point of responsibility for accomplishing project objectives and ensur...
  • 10/27/2024 12:00:00 AM

Income Estimation for Engineering Director jobs
$203,343 to $265,871