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Elektrofi · 2 days ago

Senior Director, CMC Technical Lead

Boston, MA

Full-time

Onsite

Director/Executive

$235K/yr - $285K/yr

12+ years exp

Elektrofi is revolutionizing the delivery of biologic therapies by enabling patients to control their treatment through innovative technology. The CMC Technical Lead will lead cross-functional program teams in the development and commercialization of biologics, serving as the primary technical interface with internal teams, partners, and regulatory authorities.

Alternative MedicineBiotechnologyTherapeutics

No H1B

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

Qualification

Biologics developmentCMC program leadershipRegulatory submission experienceDrug product developmentCross-functional team leadershipCommunication skillsTeam playerAttention to detail

Required

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

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