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Senior Engineer, Manufacturing Science and Technology

Richmond, Virginia

​This is a remote opportunity, however location in Richmond, VA or Indianapolis, IN is preferred.  

Kaléo has secured multiple contracts with the U.S. government for production of new medical countermeasures, with commercialization opportunity to follow. The Senior Engineer, Manufacturing Science and Technology, will provide leadership for the projects that transfer new technologies and processes from development to commercial manufacturing. Work with cross-functional teams including our Contract Manufacturing Organizations (CMOs) to ensure best-in-class quality and performance are achieved and maintained, while driving process and cost optimization. You will use your knowledge of engineering principles and automation technologies to design, program, and troubleshoot automated systems and processes, and provide workable solutions for Kaléo manufacturing.

If you are a detail-oriented engineer with experience in the medical device industry, this is an exciting opportunity to work on life-transforming products while operating within a deadline-focused environment with clear objectives and milestones. The collaborative team setting will provide you with learning support while still fostering a high degree of autonomy and responsibility in your area of expertise. Kaléo’s “remote-first” hybrid culture will offer you the flexibility to choose your work location and schedule, placing an emphasis on self-management and adherence to deadlines. At Kaléo, you can feel confident that your work has a tangible impact.  

As Senior Engineer, Manufacturing Science and Technology, you will own:

  • Technology Transfer and Technical Oversight:
    • Develop and implement a comprehensive technology transfer plan and procedures for our combination product to the CMO, ensuring seamless knowledge transfer and quality standards.
    • Provide technical oversight and ensure adherence to specifications and quality requirements.
    • Work with Manufacturing leadership and CMOs to ensure seamless technology transfer to commercial teams and partners with minimal disruptions of commercial supply commitments.
    • Assist in future product acquisition due diligence and business integration needs.
    • Provide leadership for new equipment and facility build out, including installation and commissioning and transfer to commercial manufacturing.
  • Cross-Functional Collaboration and Project Management:
    • Partner with cross-functional teams (e.g., Regulatory Affairs, R&D, Quality) to ensure smooth product development, regulatory compliance, and commercialization.
    • Authors and reviews relevant drug substance and drug product CMC sections for regulatory submissions (IND/CTA, NDA, etc).
    • Manage projects from inception to completion, including specifying and selecting new initiatives of advanced manufacturing technologies, guiding system development and installation, and delivering total process documentation to CMOs.
    • Manage project budgets and resources effectively, optimizing costs while achieving desired outcomes.
    • Act as a liaison between departments and stakeholders per project requirements.
  • Innovation and Continuous Improvement:
    • Identify and implement new technologies and processes to improve manufacturing efficiency and product quality.
    • Analyze and identify opportunities for process automation within the manufacturing environment, considering the potential benefits of AI integration, for both internal and contract manufacturing operations.
    • Stay up-to-date on industry trends and regulatory requirements for combination products.
    • Identify and implement new technologies and processes to improve manufacturing efficiency and product quality.
    • Conduct risk analyses, technical review, and engineering solutions as part the design control processes for existing product and processes in order to identify potential hazards associated with changes and associated solutions.
    • Support the building of business case(s) for process improvement projects.
    • Continuously improve existing automation and AI systems for increased efficiency, productivity, and quality across internal and contract manufacturing operations.
  • Representation and Communication:
    • Represent the MS&T function at internal and external meetings, effectively communicating technical details and project progress.
    • Develop appropriate reports and Key Performance Indicators (KPIs) to support quality improvement and new technology decisions.
    • Collaborate with internal and external engineering functions and Kaléo Development teams on key business goals and strategy; secure support and buy-in from other units to meet project objectives and/or milestones.
    • Represent Kaléo in a professional manner and uphold the highest standards of ethical business practices and the Kaléo Way values in all interactions with other employees, customers, suppliers, and other third parties.

A successful Senior Engineer, Manufacturing Science and Technology, will have:

  • Excellent communication skills, with the ability to deliver and clarify complex project information to diverse stakeholders.
  • Demonstrated leadership skills, including the ability to drive organizational strategy around new technology.
  • Innovative orientation with an outlook focused on curiosity, the future, and what’s possible.
  • Proven ability to use influence, conflict management, and collaboration skills to drive targeted business outcomes.
  • Strong analytical and problem-solving skills.
  • Hands-on and solutions-driven approach to work.
  • Demonstrated problem-solving and analytical skills.
  • Demonstrated flexibility and adaptability to changing requirements, needs, and environments.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Demonstrated ability to motivate and mentor peers and technical staff at third-party sites (such as Contract Manufacturing Organizations) by fostering a culture of continuous improvement and operational excellence.
  • Demonstrated leadership skills and ability to influence without direct authority.
  • Demonstrated expertise in the development of project plans for manufacturing transfers, including the ability to manage multiple projects.
  • Commitment to participating in and upholding an inclusive work environment. 

To be considered for the position, you must have:

  • Bachelor’s degree in a scientific or engineering discipline.
  • A minimum 10 years of progressively responsible experience.
  • Experience in technology transfer and process validation related activities, Contract Manufacturing Organization (CMO) or related environment.
  • Thorough knowledge of cGXP’s applicable to Combination Products (Drug and Device).
  • A strong understanding of combination product development design controls, including drug-device interaction, regulatory requirements, and process validation.
  • Experience with developing new products or processes in pharmaceutical drug/device combination product environments.
  • Excellent knowledge of GMP, GCP, and ICH guidelines related to clinical and commercial labeling, and packaging operations and the overall drug development process.
  • Demonstrated knowledge and application of Pharmaceutical Quality by Design (QbD) principles.
  • Ability to travel 25% or more as needed. 

Additional preferred qualifications:

  • Experience with aseptic processes and controls a plus. 
  • Experience working on government contracts a plus.

Application required for consideration. Please contact talentacquisition@kaleo.com with any additional questions.

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