Process Engineering Director jobs in Massachusetts

Process Engineering Director directs and develops a team responsible for the optimization, design, and implementation of manufacturing processes, equipment, or plants. Drives continuous improvement in process design, cost savings, quality, and resource utilization. Being a Process Engineering Director leads engineering projects, incorporates newest technologies, resolves engineering problems, approves process designs. Requires a bachelor's degree of engineering. Additionally, Process Engineering Director typically reports to top management. The Process 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. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Process Engineering Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)

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Associate Director/Director, Process Engineering and Validation
  • Kura Oncology
  • Boston, MA FULL_TIME
  • Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

    At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

    As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

    To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

    Essential Job Functions

    • Responsible for leading the engineering aspects and oversight of process development, and process validation elements for successful scale-up of chemical manufacturing processes and drug product manufacturing processes.
    • Establish criteria to ensure processes are scalable and robust for drug substance manufacture (including the related raw materials and intermediates) and the routes and strategies are suitable for commercialization.
    • Establish, review, and support process validation DOE strategies and evaluations to verify drug product processes are scalable and robust for validation and commercial launch.
    • Participate in the design of synthetic processes to target molecules (including RSMs and intermediates) to develop cost-efficient, scalable and robust drug substance manufacturing processes.
    • Provide strategic planning as well as technical support and management for contract manufacturing organization (CDMO's) to prepare manufacturing batches.
    • Review and approve associated development reports and other development-related documents.
    • Guide external third parties through technology transfer, process development, optimization, qualification, and validation of the activities related to DS and DP manufacturing operations. Be on-site, as necessary.
    • Collaborate with other functions to assure compliance with applicable GMP and global regulatory requirements.
    • Author and review of CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs).
    • Provide technical strategic support and documentation for answering questions during regulatory submission reviews.

    Job Requirements

    • BS/MS, or Ph.D. in Chemical Engineering
    • A minimum of 10 years' industry experience in process development and validation of API and/or DP processes as well as CDMO management
    • Strong knowledge of cGMP requirements relating to drug substance and drug products
    • Strong knowledge of DS/DP process development, manufacture and validation.
    • Demonstrated knowledge of late-stage development, process registration, validation, and launch is required
    • Excellent planning and organizational skills
    • Able to make international and domestic travel
    • Thorough understanding of cGMP compliance and ICH guidelines
    • Experience with managing outsourced projects with CDMOs and contractors
    • Strong leadership, teamwork, and collaboration skills
    • Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment
    • Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment

    Kura's Values that are used for candidate selection and performance assessments:

    • We work as one for patients
    • We are goal-focused and deliver with excellence
    • We are science-driven courageous innovators
    • We strive to bring out the best in each other and ourselves

    The Kura Package

    • Career advancement/ development opportunities
    • Competitive comp package
    • Bonus
    • 401K Employer contributions
    • Generous stock options
    • ESPP Plan
    • 20 days of PTO to start
    • 18 Holidays (Including Summer & Winter Break)
    • Generous Benefits Package with a variety of plans available with a substantial employer match
    • Paid Paternity/Maternity Leave
    • In-Office Catered lunches
    • Home Office Setup
    • Lifestyle Spending Stipend
    • Commuter Stipend (Boston Office)
    • Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

    Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.

    Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura's website at www.kuraoncology.com.

    Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

     

  • 16 Days Ago

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Process Engineer, RMTO Process Engineering
  • myGwork - LGBTQ+ Business Community
  • Westborough, MA FULL_TIME
  • This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ business community. DescriptionAre you inspired by invention? Is problem solving through teamwork in your DNA...
  • 3 Days Ago

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Process Engineer, RMTO Process Engineering
  • Amazon
  • North Reading, MA FULL_TIME
  • DESCRIPTIONAre you inspired by invention? Is problem solving through teamwork in your DNA? We apply advances in robotics and software to solve real-world problems that delight our customers' experienc...
  • 23 Days Ago

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Process Engineer, RMTO Process Engineering
  • Amazon
  • Westborough, MA FULL_TIME
  • DESCRIPTIONAre you inspired by invention? Is problem solving through teamwork in your DNA? We apply advances in robotics and software to solve real-world problems that delight our customers' experienc...
  • 2 Months Ago

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Process Engineering Manager, RMTO Process Engineering
  • Amazon.com Services LLC
  • Westborough, MA FULL_TIME
  • · Bachelor’s degree. · 5 years’ experience in manufacturing environment and knowledge of GMP. ·Expereince in Engineering Management · Ability to manage and deliver projects with accelerated schedules....
  • 7 Days Ago

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Process Engineering Manager, RMTO Process Engineering
  • Amazon
  • Westborough, MA FULL_TIME
  • DESCRIPTION Are you inspired by invention? Is problem solving through teamwork in your DNA? We apply advances in robotics and software to solve real-world problems that delight our customers' experien...
  • 7 Days Ago

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Director of Engineering
  • SmartTalent Staffing and Recruiting
  • Auburn, WA
  • SmartHire is hiring an Engineering Director for a Manufacturing company in Auburn. Ideal candidate will have a minimum o...
  • 6/2/2024 12:00:00 AM

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Engine Director
  • Peak Performance Recruitment
  • Miami, FL
  • As a premier engine material and support services company, we specialize in being an engine aftermarket parts stockist a...
  • 6/1/2024 12:00:00 AM

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Process Engineer, Director, E6
  • Applied Materials
  • Santa Clara, CA
  • **Key Responsibilities** 1. Leads practical applications of scientific theory and unusually complex processes in the dev...
  • 5/31/2024 12:00:00 AM

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Director of Engineering
  • Ascendion
  • Pittsburgh, PA
  • About Ascendion: Ascendion is a full-service digital engineering solutions company. We make and manage software platform...
  • 5/31/2024 12:00:00 AM

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Director of Engineering
  • SmartHire
  • Auburn, WA
  • Job Description Job Description SmartHire is hiring an Engineering Director for a Manufacturing company in Auburn. Ideal...
  • 5/31/2024 12:00:00 AM

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Director of Engineering
  • PSG
  • Cincinnati, OH
  • PSG® is the global pump, metering and dispensing-solution expert, enabling the safe and efficient transfer of critical a...
  • 5/30/2024 12:00:00 AM

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Director of Engineering
  • EVONA
  • Are you tired of city living, long commutes and nothing to do? I am looking for an engineering director who loves the ou...
  • 5/30/2024 12:00:00 AM

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Regional Process Engineering Director
  • Summit Interconnect, Inc. - Anaheim
  • Anaheim, CA
  • Job Description Job Description Summit Interconnect currently has an open position for a Regional Process Engineering Di...
  • 5/29/2024 12:00:00 AM

Massachusetts is the 7th-smallest state in the United States. It is located in the New England region of the northeastern United States and has an area of 10,555 square miles (27,340 km2), 25.7% of which is water. Several large bays distinctly shape its coast. Boston is the largest city, at the inmost point of Massachusetts Bay, and the mouth of the Charles River. Despite its small size, Massachusetts features numerous topographically distinctive regions. The large coastal plain of the Atlantic Ocean in the eastern section of the state contains Greater Boston, along with most of the state's po...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Process Engineering Director jobs
$200,113 to $248,145

Process Engineering Director in Chicago, IL
We have designed an evaluation process that mitigates the risk by identifying folks who have the skills and attributes to succeed at Asana.
January 21, 2020
The Process Engineering Manager, under the strategic direction of the Director of Plant Engineering is responsible for supporting manufactur.
January 07, 2020
Process Engineering Director in Davenport, IA
We are looking for an experienced Process Engineer to join our dream team engineering team an take on full responsibility for our process implementation and improvement.
February 09, 2020
Process Engineering Director in Temple, TX
The Process Engineer Manager will be in charge of a fast growing team.
December 30, 2019