Director of Engineering

Elektrofi IncBoston, MA, US

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Job Description

Description : ABOUT ELEKTROFI

Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously administered biologic therapies by enabling convenient at-home subcutaneous self-administration. With a focus on monoclonal antibodies, therapeutic proteins, and other biologics, we partner with companies to develop and commercialize our novel Hypercon™ formulations. We believe a patient-centered healthcare approach can lead to a healthier world. We are headquartered in Boston and innovate globally. We are Formulating the Future of Biologics™.

POSITION SUMMARY

Elektrofi is seeking a motivated individual to join our biotech company as a Director of Engineering to support the design, fabrication, and qualification of our novel aseptic microparticle formulation platform.

The Head of Engineering is a highly skilled and experienced technical engineering leader who will lead and manage stakeholders cross-functionally both internally and externally. The work for this role is highly matrixed with the complexity of working on several capital projects in parallel as the company executes the 5-year manufacturing strategy for projected growth. This role will be responsible for overseeing the planning, execution, and successful delivery of capital engineering projects. The ideal candidate will have a strong background in engineering management, process engineering design, excellent leadership capabilities, and a proven track record of driving project success. Experience with multi-million-dollar capital projects and having a PE (Professional Engineer) License is preferred.

The role will serve as an interface between Program Management, Process Development, MS&T, Quality, Supply Chain, and Legal for internal, partner, and CDMO stakeholders. Global travel up to 30% of the time may be required during startup of new manufacturing sites to support technology transfer. The individual should thrive in a fast-paced and dynamic environment and be a key player in the company’s growth. The individual will join a growing, multidisciplinary team of scientists / engineers and industry professionals.

KEY RESPONSIBILITIES

Leadership and Management : Provide strategic direction and leadership for the project engineering & process engineering projects, ensuring alignment with company goals and objectives.
Project Oversight : Oversee the planning, scheduling, and execution of engineering projects, ensuring they are completed on time, within scope, and budget.
Stakeholder Communication : Act as the primary point of contact for project stakeholders, including partners, upper management, and cross-functional teams, ensuring clear and effective communication.
Resource Allocation : Manage and allocate resources effectively to optimize project execution and team performance.
Risk Management : Identify potential risks and develop mitigation strategies to ensure project success and minimize impact.
Quality Assurance : Ensure all projects meet the highest quality standards, adhering to industry regulations and company policies.
Design, Fabrication, Qualification : Ensure all DQ, IOQ, AOQ, and commissioning activities are completed to company or partner standards.
Continuous Improvement : Drive continuous improvement initiatives to enhance project processes, tools, and methodologies.
Team Development : Mentor and develop company engineers and scientists, fostering a culture of growth, innovation, and excellence.

Requirements :

MINIMUM QUALIFICATIONS

Education : Bachelor’s degree in mechanical or chemical engineering, or a related field. MS / MENG preferred.

Experience : 10+ years of experience in engineering project management, with at least 5 years in a leadership role.

Technical Expertise : Strong technical background in engineering principles and practices, pharmaceutical industry experience is preferred.

Leadership Skills : Proven ability to lead & inspire a project team of engineers and project managers.

Travel : up to 30% travel to equipment suppliers, CDMOs, and partner sites may be required.

Project Management : Extensive experience in managing complex engineering projects, equipment qualification, including budgeting, scheduling, and resource allocation.

Communication : Excellent verbal and written communication skills, with the ability to effectively interact with stakeholders at all levels.

Problem-Solving : Strong analytical and problem-solving skills, with the ability to make sound decisions under pressure.

Adaptability : Ability to adapt to changing priorities and manage multiple projects simultaneously.

General Knowledge of ISO, FDA CFR, EMA Annex 1 standards for GMP manufacturing.

Experience managing external engineering firms and fabrication shops.

Strong understanding of lean manufacturing, DQ, IOQ, automation and process validation.

Ability to conduct FMEA analysis. Create, review, and approve P&IDs and 3D equipment models.

License / Certifications : Professional Engineer preferred. PMP, Six Sigma, or other relevant certifications are a plus.

Our unique strength lies in transforming pioneering ideas into concrete, life-transforming solutions. To realize this ambitious vision, we are dedicated to nurturing an in-office work ethos. While remote work has its merits, it does not constitute a fundamental aspect of our working approach. Please apply at elektrofi.com / careers.

EEOC Statement :

Elektrofi provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

To all agencies, please, no phone calls or emails to any employee of Elektrofi about this requisition. All resumes submitted by search firms / employment agencies to any employee at Elektrofi via email, the internet, or in any form and method will be deemed the sole property of Elektrofi unless such search firms / employment agencies were engaged by Elektrofi for this requisition and a valid agreement with Elektrofi is in place. If a candidate submitted outside of the Elektrofi agency engagement process is hired, no fee or payment of any kind will be paid.

All candidates must be legally authorized to work in the US.

LI-Onsite

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Director Of Engineering • Boston, MA, US