Senior Director, CMC Technical Lead

Job Type

Full-time

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 an experienced CMC Technical Lead to join our Program Management and Portfolio Strategy team. This is a technical role that will lead cross-functional program teams – from early development through launch. This role will serve as the primary technical and strategic interface between internal cross-functional teams, external partners, and regulatory authorities to ensure successful development of biologics on the Hypercon™ Platform. The role requires dynamic leadership expertise in biologics nonclinical development and CMC and strong decision-making abilities.

Key Responsibilities

• Drive the development and implementation of the integrated scientific, technical, and regulatory strategy of programs in the portfolio ensuring alignment with overall program objectives and regulatory requirements.
• Partner with the program manager, functional heads, and technical SMEs to integrate nonclinical, formulation, process and analytical development, manufacturing and regulatory plans.
• Partner with the program manager, functional heads, and technical SMEs to identify risks, and implement mitigation strategies for each program.
• Support regulatory strategy development and health authority interactions as the lead contributor.
• Act as the primary technical interface between the company and Alliance Partners, ensuring transparent communication and alignment.
• Facilitate effective decision-making by preparing clear program updates, risk assessments, and recommendations for governance and senior leadership.
• Facilitate technical governance meetings, decision-making forums, and stage-gate readiness reviews.
• Serve as the primary interface between the Program team and Company leadership, ensuring that the program’s technical strategy and operational plans are aligned with Elektrofi’s short- and long-term goals.
• Foster a collaborative, high-performing team environment that encourages accountability and solution-oriented thinking.
  
  

Requirements

MINIMUM QUALIFICATIONS

• Advanced degree (BS considered with strong experience) in scientific or engineering discipline.
• 12 years of biotech/pharma industry experience, including 5 years of CMC program leadership in biologics development.
• Proven ability to lead complex, cross-functional teams in a matrix environment.
• Ability to operate strategically while also managing tactical execution details.
• Strong team player who can rapidly build positive relationships, proactively partner across teams with the ability to motivate and influence others and negotiate diplomatically.
• Deep understanding of end-to-end drug product development, manufacturing, and regulatory expectations for biologics. Experience working with high-concentration and subcutaneous formulations is preferred.
• Strong understanding of biologics CMC development, from preclinical through clinical stages with regulatory submission experience (IND/CTA, BLA/MAA).
• Excellent oral and written communication skills, and attention to detail to ensure high quality presentations and regulatory submissions.
  
  

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.

Salary Description

$235,000 - $285,000